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22653314
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CONCLUSION: This analysis provides a current evidence-based estimate of PACG prevalence in European derived populations and suggests there are 130,000 people in the UK, 1.60 million people in Europe and 581,000 people in the USA with PACG today. Accounting for ageing population structures, cases are predicted to increase by 19% in the UK, 9% in Europe and 18% in the USA within the next decade. PACG is more common than previously thought, and all primary glaucoma cases should be considered to be PACG until the anterior chamber angle is shown to be open on gonioscopy.
|
PURPOSE: Primarily to determine the prevalence of various types of glaucoma and ocular hypertension in Wroclaw inhabitants aged 40-79 years. The second aim of the study was to determine the number of undiagnosed glaucoma cases in this population.
METHODS: A representative group of the Wroclaw population (4853 people aged from 40 to 79 years) was recruited by a proportional simple random sampling selection with stratification. All participants underwent the first, screening-stage examination, which included a medical history interview, intraocular pressure (IOP) measurement, anterior chamber depth assessment by the Van Herrick technique, and optic nerve head (ONH) assessment by means of indirect ophthalmoscopy (Volk's lens), confocal scanning laser ophthalmoscopy with a Heidelberg Retinal Tomograph (HRT) and scanning laser polarimetry by the GDx Nerve Fiber Analyzer (GDx). The second stage, in glaucoma-suspect patients only, included best corrected visual acuity, static perimetry, 24-hour monitoring of IOP, gonioscopy, and full eye examination with mydriasis. Glaucoma was diagnosed by the presence of any two of the following: characteristic morphological changes in the optic disc, glaucomatous visual field abnormalities, and intraocular pressure greater than 21 mmHg.
RESULTS: The overall prevalence of glaucoma was 1.6% (79 subjects). The prevalence increased with age from 0.4% in subjects belonging to the age group 40-49 years to 4.6% in people aged between 70 and 79 years. The prevalence of definite primary open-angle glaucoma was 1.0% (49 subjects). Normal-pressure glaucoma was diagnosed in 13 subjects (0.3%). Ocular hypertension was diagnosed in 92 subjects (1.9%).
CONCLUSION: The prevalence of the different types of glaucoma was similar to that found in other white populations. Among the subjects examined, 79 had various forms of glaucoma and 71% of them had not previously been diagnosed. Undiagnosed glaucoma is a serious public health problem in Poland. ||||| OBJECTIVE: The purpose of the study is to assess the prevalence of various types of glaucoma and to determine the intraocular pressure (IOP) distribution in a defined population in an Italian rural community.
DESIGN: A cross-sectional epidemiologic study in a defined population was planned. After the screening examination, the subjects with suspected glaucoma were re-examined at the screening center in order to confirm the diagnosis. All cases that still proved suspect after the second examination underwent a third phase of investigations at the Ophthalmologic Division of Bolzano Hospital, and were classified as healthy or definitely glaucomatous.
PARTICIPANTS: All subjects residing in the Egna-Neumarkt area of Alto Adige region (Northern Italy) and over 40 years of age were invited to undergo an ophthalmologic examination.
INTERVENTION: Each subject was examined according to a standard protocol, including computerized perimetry, applanation tonometry, evaluation of anterior chamber depth and optic disc, and a medical history interview. The diagnosis of glaucoma was based on the presence of at least two of the following criteria: IOP > or = 22 mmHg, glaucomatous optic disc abnormalities, and glaucomatous visual field defects. Ocular hypertension was defined as IOP > or = 22 mmHg without visual field or glaucomatous optic disc abnormalities.
MAIN OUTCOME MEASURES: Participation rate, mean IOP, prevalence of glaucoma (primary open-angle glaucoma, primary angle-closure glaucoma, normal-tension glaucoma, secondary glaucoma), and ocular hypertension were determined.
RESULTS: Of a total of 5816, 4297 subjects were examined (73.9% overall participation rate). Intraocular pressure showed a Gaussian-like distribution curve skewed to the right. Mean IOP increased with age, and was slightly higher in men (15.14 mmHg) than in women (14.94 mmHg). The overall prevalences of ocular hypertension, primary open-angle glaucoma, primary angle-closure glaucoma, and normal-tension glaucoma were 2.1%, 1.4%, 0.6%, and 0.6%, respectively. Only 28 of 210 patients with glaucoma or ocular hypertension had been diagnosed prior to the screening.
CONCLUSIONS: The distribution of IOP and the prevalence of the different types of glaucoma were similar to those found in other white populations. ||||| PURPOSE: The purpose of this study was to determine the prevalence of open-angle glaucoma and ocular hypertension in an Australian community whose residents are 49 years of age or older.
SUBJECTS: There were 3654 persons, representing 82.4% of permanent residents from an area west of Sydney, Australia, who were examined. The population was identified by a door-to-door census of all dwellings and by closely matched findings from the national census.
METHODS: All participants received a detailed eye examination, including applanation tonometry, suprathreshold automated perimetry (Humphrey 76-point test), and Zeiss stereoscopic optic disc photography. Glaucoma suspects were asked to return for full threshold fields (Humphrey 30-2 test), gonioscopy, and repeat tonometry.
RESULTS: A 5-point hemifield difference on the 76-point test was found in 616 persons (19% of people tested). Humphrey 30-2 tests were performed on 336 glaucoma suspects (9.2% of population), of whom 125 had typical glaucomatous field defects. Two hundred three persons had enlarged or asymmetric cup-disc ratios (> or = 0.7 in 1 or both eyes or a cup-disc ratio difference of > or = 0.3). Open-angle glaucoma was diagnosed when glaucomatous defects on the 30-2 test matched the optic disc changes, without regard to the intraocular pressure level. This congruence was found in 87 participants (2.4%), whereas an additional 21 persons (0.6%) had clinical signs of open-angle glaucoma but incomplete examination findings. Open-angle glaucoma was thus found in 108 persons, a prevalence of 3.0% (95% confidence interval [CI], 2.5-3.6), of whom 49% were diagnosed previously. An exponential rise in prevalence was observed with increasing age. Ocular hypertension, defined as an intraocular pressure in either eye greater than 21 mmHg, without matching disc and field changes, was present in 3.7% of this population (95% CI, 3.1-4.3), but there was no significant age-related increase in prevalence. The prevalence of glaucoma was higher in women after adjusting for age (odds ratio, 1.5; CI, 1.0-2.2). There was no sex difference in the age-adjusted prevalence of ocular hypertension.
CONCLUSIONS: These data provide detailed age and sex-specific prevalence rates for open-angle glaucoma and ocular hypertension in an older Australian population. ||||| OBJECTIVE: To assess the prevalence of primary angle-closure glaucoma (PACG), the frequency of its different clinical presentations, and its association with peripheral anterior chamber depth in a defined population in Northern Italy.
DESIGN: Cross-sectional epidemiologic study in a defined population.
PARTICIPANTS: All subjects resident in the Egna-Neumarkt area of the South Tyrol Region (Northern Italy) and more than 40 years of age were invited to undergo an ophthalmologic examination.
INTERVENTION: After the screening examination, subjects with suspected glaucoma were re-examined at the screening center to confirm the diagnosis. All cases that still proved suspect after the second examination underwent a third phase of investigations and were classified as healthy or as definitely glaucomatous. Each subject was examined according to a standard protocol, including medical history interview, refraction and visual acuity determination, ocular biomicroscopy, evaluation of peripheral anterior chamber depth by means of the Van Herick method, applanation tonometry, optic disc evaluation, and computerized perimetry. Gonioscopy was not performed during initial screening but only in all selected patients in the second and third phases of investigations. The diagnosis of PACG was made on the basis of the concomitant presence of at least two of the following criteria: intraocular pressure > or = 22 mmHg, glaucomatous optic disc abnormalities, glaucomatous visual field defects. In addition, biomicroscopic or gonioscopic evidence of angle closure was also necessary.
MAIN OUTCOME MEASURES: Percentage distribution of peripheral anterior chamber depths, prevalence of angle-closure glaucoma, and frequency of the different PACG clinical presentations.
RESULTS: Four thousand two hundred ninety-seven subjects were examined (73.9% overall participation rate). The peripheral depth of the anterior chamber according to the Van Herick method was grade 2 in 14.7%, grade 1 in 2.5%, and grade 0 in 0.3% of the population. The overall prevalence of angle-closure glaucoma was 0.6% (26 cases). Five of these were cases of previous acute attacks resolved by therapy, three were cases of chronic angle-closure after acute attacks, three were intermittent angle-closure glaucomas, and 15 were chronic angle-closure cases.
CONCLUSIONS: Occludable angles were more frequent than in other white populations previously studied. The prevalence of PACG is not as low as is usually believed; this type of glaucoma accounts for more than a quarter of all glaucomas found in the Egna-Neumarkt population. The most frequent clinical presentation is chronic angle-closure glaucoma. ||||| The Baltimore Eye Survey was a population-based survey conducted from January 1985 to November 1988 among residents of east Baltimore, Maryland, who were 40 years of age or older. A total of 5,308 black subjects and white subjects received a comprehensive screening examination for glaucoma including tonometry, visual fields, stereoscopic fundus photography, and a detailed medical and ophthalmic history. Based on a definitive examination, a diagnosis of glaucoma of any type was made for 196 persons. Tonometry, cup:disc ratio, and narrowest neuroretinal rim width were evaluated for their ability to correctly classify subjects into diseased or nondiseased states. There were no cutoff values at which these variables provided a reasonable balance of sensitivity and specificity, separately or in combination. Logistic regression models were fit that included demographic and other risk factors. Sensitivities and specificities were calculated for varying cutoff levels on the distribution of predicted probabilities. There was no cutoff for which reasonable sensitivity and specificity were obtained. The authors conclude that the effectiveness of current techniques for glaucoma screening is limited. ||||| PURPOSE: The objective of this study is to assess the prevalence of primary open-angle glaucoma (POAG) in a defined population in Rotterdam, The Netherlands.
METHODS: The Rotterdam Study is a single-center prospective cohort study of a total population of more than 10,000 people, 55 years of age or older. For the current analysis, the first 3062 consecutive, unselected, noninstitutionalized participants were examined according to standard protocols, including perimetry. The diagnosis of POAG was based on the presence of a glaucomatous visual field defect combined with either a vertical cup: disc ratio of 0.5 or more or a cup:disc ratio asymmetry of 0.2 or more, or an intraocular pressure (IOP) more than 21 mmHg, with open and normal anterior chamber angles.
RESULTS: The overall prevalence of POAG in the current study was 1.10% (95% confidence interval [CI]: 1.09, 1.11). Age-specific prevalence figures increased from 0.2% (95% CI: 0.16, 0.24) in the age group of 55 to 59 years to 3.3% (95% CI: 2.57, 4.04) in the age group of 85 to 89 years. Men had a more than three times higher risk of having POAG than women (odds ratio, 3.6). In 52.9% of the patients, POAG had not been diagnosed previously. Of these patients, 38.9% had IOPs of 21 mmHg or lower. In 8.8% of the eyes (2.9% of patients), visual acuity was 20/200 or less due to POAG.
CONCLUSION: The overall prevalence of POAG in the current study was 1.1%. The prevalence of POAG was higher in men than in women. Of the untreated patients, 38.9% had IOPs of 21 mmHg or lower. ||||| The purpose of this study was to determine the prevalence of glaucoma in Ponza, Italy. The design was a population-based prevalence survey of residents of Ponza aged 40 years or older. There were 1,296 official residents identified by a house-to-house census, of whom 1,226 were identified as eligible for the study. Of these, 1,034 individuals (449 males and 585 females), or 84.3% of the eligible population, participated in the ophthalmological examination. A two-stage method was adopted to identify cases of glaucoma. All subjects underwent a standardized initial examination. Glaucoma suspects and 50% of non-suspects were referred to a definitive examination which included visual field testing. Patients were defined as glaucoma cases if they presented abnormal visual fields and at least one of the following: high 10P, large or asymmetric cup-to-disc ratio. In addition to typical glaucomatous visual field defects such as paracentral scotoma, nasal step, arcuate scotoma and temporal and/or central islands fields, a visual field defect was identified as a decrease in sensitivity greater than 6 db in at least one location of the central 10 degrees, two locations of the central 20 degrees or three locations of the central 30 degrees. Prevalence rates of 2.51% of Primary Open Angle Glaucoma (1.72%-3.66%, CI 95%), 0.97% of Primary Closed Angle Glaucoma (0.53%-1.77%, CI 95%) and 0.29% of secondary glaucoma were found. Moreover, 2.13% of probable POAG (1.41%-3.20%, CI 95%) and 6.00% of High Intraocular Pressure (4.71%-7.61%, CI 95%) were found. The prevalence rates of POAG found in the Ponza Ophthalmological Survey are consistent with the results of other studies. Minor differences are most likely due to the different criteria adopted in the assessment of glaucomatous visual field damage. ||||| OBJECTIVE: To determine the prevalence of glaucoma among black and white persons 73 years and older.
DESIGN: Participants in the fourth round of a population-based study, the Salisbury Eye Evaluation, were examined. The main outcome measure was glaucoma, based on optic nerve damage and visual field loss or obvious glaucomatous optic neuropathy without an available, reliable, reproducible visual field.
RESULTS: A total of 1250 individuals (95.9% of those eligible) participated, 1233 (98.6%) of whom agreed to screening and an eye examination. The prevalence (95% confidence interval) of open-angle glaucoma was 3.4% (0.5%-6.4%) for white individuals aged 73 and 74 years, increasing to 9.4% (7.4%-11.5%) for those 75 years and older. There was no increasing prevalence in those older than 75 years. Among black persons, the prevalence (95% confidence interval) was 5.7% (0%-11.9%) in those aged 73 and 74 years and 23.2% (17.8%-28.5%) in those 75 years and older.
CONCLUSIONS: Many older individuals have open-angle glaucoma, and black persons 75 years and older have substantially higher rates than whites. These findings have important implications for public health initiatives, in which screening programs may be of benefit.
|
[
{
"source_pmid": "16283988",
"source_text": "PURPOSE: Primarily to determine the prevalence of various types of glaucoma and ocular hypertension in Wroclaw inhabitants aged 40-79 years. The second aim of the study was to determine the number of undiagnosed glaucoma cases in this population.\nMETHODS: A representative group of the Wroclaw population (4853 people aged from 40 to 79 years) was recruited by a proportional simple random sampling selection with stratification. All participants underwent the first, screening-stage examination, which included a medical history interview, intraocular pressure (IOP) measurement, anterior chamber depth assessment by the Van Herrick technique, and optic nerve head (ONH) assessment by means of indirect ophthalmoscopy (Volk's lens), confocal scanning laser ophthalmoscopy with a Heidelberg Retinal Tomograph (HRT) and scanning laser polarimetry by the GDx Nerve Fiber Analyzer (GDx). The second stage, in glaucoma-suspect patients only, included best corrected visual acuity, static perimetry, 24-hour monitoring of IOP, gonioscopy, and full eye examination with mydriasis. Glaucoma was diagnosed by the presence of any two of the following: characteristic morphological changes in the optic disc, glaucomatous visual field abnormalities, and intraocular pressure greater than 21 mmHg.\nRESULTS: The overall prevalence of glaucoma was 1.6% (79 subjects). The prevalence increased with age from 0.4% in subjects belonging to the age group 40-49 years to 4.6% in people aged between 70 and 79 years. The prevalence of definite primary open-angle glaucoma was 1.0% (49 subjects). Normal-pressure glaucoma was diagnosed in 13 subjects (0.3%). Ocular hypertension was diagnosed in 92 subjects (1.9%).\nCONCLUSION: The prevalence of the different types of glaucoma was similar to that found in other white populations. Among the subjects examined, 79 had various forms of glaucoma and 71% of them had not previously been diagnosed. Undiagnosed glaucoma is a serious public health problem in Poland."
},
{
"source_pmid": "9479277",
"source_text": "OBJECTIVE: The purpose of the study is to assess the prevalence of various types of glaucoma and to determine the intraocular pressure (IOP) distribution in a defined population in an Italian rural community.\nDESIGN: A cross-sectional epidemiologic study in a defined population was planned. After the screening examination, the subjects with suspected glaucoma were re-examined at the screening center in order to confirm the diagnosis. All cases that still proved suspect after the second examination underwent a third phase of investigations at the Ophthalmologic Division of Bolzano Hospital, and were classified as healthy or definitely glaucomatous.\nPARTICIPANTS: All subjects residing in the Egna-Neumarkt area of Alto Adige region (Northern Italy) and over 40 years of age were invited to undergo an ophthalmologic examination.\nINTERVENTION: Each subject was examined according to a standard protocol, including computerized perimetry, applanation tonometry, evaluation of anterior chamber depth and optic disc, and a medical history interview. The diagnosis of glaucoma was based on the presence of at least two of the following criteria: IOP > or = 22 mmHg, glaucomatous optic disc abnormalities, and glaucomatous visual field defects. Ocular hypertension was defined as IOP > or = 22 mmHg without visual field or glaucomatous optic disc abnormalities.\nMAIN OUTCOME MEASURES: Participation rate, mean IOP, prevalence of glaucoma (primary open-angle glaucoma, primary angle-closure glaucoma, normal-tension glaucoma, secondary glaucoma), and ocular hypertension were determined.\nRESULTS: Of a total of 5816, 4297 subjects were examined (73.9% overall participation rate). Intraocular pressure showed a Gaussian-like distribution curve skewed to the right. Mean IOP increased with age, and was slightly higher in men (15.14 mmHg) than in women (14.94 mmHg). The overall prevalences of ocular hypertension, primary open-angle glaucoma, primary angle-closure glaucoma, and normal-tension glaucoma were 2.1%, 1.4%, 0.6%, and 0.6%, respectively. Only 28 of 210 patients with glaucoma or ocular hypertension had been diagnosed prior to the screening.\nCONCLUSIONS: The distribution of IOP and the prevalence of the different types of glaucoma were similar to those found in other white populations."
},
{
"source_pmid": "8874440",
"source_text": "PURPOSE: The purpose of this study was to determine the prevalence of open-angle glaucoma and ocular hypertension in an Australian community whose residents are 49 years of age or older.\nSUBJECTS: There were 3654 persons, representing 82.4% of permanent residents from an area west of Sydney, Australia, who were examined. The population was identified by a door-to-door census of all dwellings and by closely matched findings from the national census.\nMETHODS: All participants received a detailed eye examination, including applanation tonometry, suprathreshold automated perimetry (Humphrey 76-point test), and Zeiss stereoscopic optic disc photography. Glaucoma suspects were asked to return for full threshold fields (Humphrey 30-2 test), gonioscopy, and repeat tonometry.\nRESULTS: A 5-point hemifield difference on the 76-point test was found in 616 persons (19% of people tested). Humphrey 30-2 tests were performed on 336 glaucoma suspects (9.2% of population), of whom 125 had typical glaucomatous field defects. Two hundred three persons had enlarged or asymmetric cup-disc ratios (> or = 0.7 in 1 or both eyes or a cup-disc ratio difference of > or = 0.3). Open-angle glaucoma was diagnosed when glaucomatous defects on the 30-2 test matched the optic disc changes, without regard to the intraocular pressure level. This congruence was found in 87 participants (2.4%), whereas an additional 21 persons (0.6%) had clinical signs of open-angle glaucoma but incomplete examination findings. Open-angle glaucoma was thus found in 108 persons, a prevalence of 3.0% (95% confidence interval [CI], 2.5-3.6), of whom 49% were diagnosed previously. An exponential rise in prevalence was observed with increasing age. Ocular hypertension, defined as an intraocular pressure in either eye greater than 21 mmHg, without matching disc and field changes, was present in 3.7% of this population (95% CI, 3.1-4.3), but there was no significant age-related increase in prevalence. The prevalence of glaucoma was higher in women after adjusting for age (odds ratio, 1.5; CI, 1.0-2.2). There was no sex difference in the age-adjusted prevalence of ocular hypertension.\nCONCLUSIONS: These data provide detailed age and sex-specific prevalence rates for open-angle glaucoma and ocular hypertension in an older Australian population."
},
{
"source_pmid": "10811096",
"source_text": "OBJECTIVE: To assess the prevalence of primary angle-closure glaucoma (PACG), the frequency of its different clinical presentations, and its association with peripheral anterior chamber depth in a defined population in Northern Italy.\nDESIGN: Cross-sectional epidemiologic study in a defined population.\nPARTICIPANTS: All subjects resident in the Egna-Neumarkt area of the South Tyrol Region (Northern Italy) and more than 40 years of age were invited to undergo an ophthalmologic examination.\nINTERVENTION: After the screening examination, subjects with suspected glaucoma were re-examined at the screening center to confirm the diagnosis. All cases that still proved suspect after the second examination underwent a third phase of investigations and were classified as healthy or as definitely glaucomatous. Each subject was examined according to a standard protocol, including medical history interview, refraction and visual acuity determination, ocular biomicroscopy, evaluation of peripheral anterior chamber depth by means of the Van Herick method, applanation tonometry, optic disc evaluation, and computerized perimetry. Gonioscopy was not performed during initial screening but only in all selected patients in the second and third phases of investigations. The diagnosis of PACG was made on the basis of the concomitant presence of at least two of the following criteria: intraocular pressure > or = 22 mmHg, glaucomatous optic disc abnormalities, glaucomatous visual field defects. In addition, biomicroscopic or gonioscopic evidence of angle closure was also necessary.\nMAIN OUTCOME MEASURES: Percentage distribution of peripheral anterior chamber depths, prevalence of angle-closure glaucoma, and frequency of the different PACG clinical presentations.\nRESULTS: Four thousand two hundred ninety-seven subjects were examined (73.9% overall participation rate). The peripheral depth of the anterior chamber according to the Van Herick method was grade 2 in 14.7%, grade 1 in 2.5%, and grade 0 in 0.3% of the population. The overall prevalence of angle-closure glaucoma was 0.6% (26 cases). Five of these were cases of previous acute attacks resolved by therapy, three were cases of chronic angle-closure after acute attacks, three were intermittent angle-closure glaucomas, and 15 were chronic angle-closure cases.\nCONCLUSIONS: Occludable angles were more frequent than in other white populations previously studied. The prevalence of PACG is not as low as is usually believed; this type of glaucoma accounts for more than a quarter of all glaucomas found in the Egna-Neumarkt population. The most frequent clinical presentation is chronic angle-closure glaucoma."
},
{
"source_pmid": "1746520",
"source_text": "The Baltimore Eye Survey was a population-based survey conducted from January 1985 to November 1988 among residents of east Baltimore, Maryland, who were 40 years of age or older. A total of 5,308 black subjects and white subjects received a comprehensive screening examination for glaucoma including tonometry, visual fields, stereoscopic fundus photography, and a detailed medical and ophthalmic history. Based on a definitive examination, a diagnosis of glaucoma of any type was made for 196 persons. Tonometry, cup:disc ratio, and narrowest neuroretinal rim width were evaluated for their ability to correctly classify subjects into diseased or nondiseased states. There were no cutoff values at which these variables provided a reasonable balance of sensitivity and specificity, separately or in combination. Logistic regression models were fit that included demographic and other risk factors. Sensitivities and specificities were calculated for varying cutoff levels on the distribution of predicted probabilities. There was no cutoff for which reasonable sensitivity and specificity were obtained. The authors conclude that the effectiveness of current techniques for glaucoma screening is limited."
},
{
"source_pmid": "7800368",
"source_text": "PURPOSE: The objective of this study is to assess the prevalence of primary open-angle glaucoma (POAG) in a defined population in Rotterdam, The Netherlands.\nMETHODS: The Rotterdam Study is a single-center prospective cohort study of a total population of more than 10,000 people, 55 years of age or older. For the current analysis, the first 3062 consecutive, unselected, noninstitutionalized participants were examined according to standard protocols, including perimetry. The diagnosis of POAG was based on the presence of a glaucomatous visual field defect combined with either a vertical cup: disc ratio of 0.5 or more or a cup:disc ratio asymmetry of 0.2 or more, or an intraocular pressure (IOP) more than 21 mmHg, with open and normal anterior chamber angles.\nRESULTS: The overall prevalence of POAG in the current study was 1.10% (95% confidence interval [CI]: 1.09, 1.11). Age-specific prevalence figures increased from 0.2% (95% CI: 0.16, 0.24) in the age group of 55 to 59 years to 3.3% (95% CI: 2.57, 4.04) in the age group of 85 to 89 years. Men had a more than three times higher risk of having POAG than women (odds ratio, 3.6). In 52.9% of the patients, POAG had not been diagnosed previously. Of these patients, 38.9% had IOPs of 21 mmHg or lower. In 8.8% of the eyes (2.9% of patients), visual acuity was 20/200 or less due to POAG.\nCONCLUSION: The overall prevalence of POAG in the current study was 1.1%. The prevalence of POAG was higher in men than in women. Of the untreated patients, 38.9% had IOPs of 21 mmHg or lower."
},
{
"source_pmid": "9243650",
"source_text": "The purpose of this study was to determine the prevalence of glaucoma in Ponza, Italy. The design was a population-based prevalence survey of residents of Ponza aged 40 years or older. There were 1,296 official residents identified by a house-to-house census, of whom 1,226 were identified as eligible for the study. Of these, 1,034 individuals (449 males and 585 females), or 84.3% of the eligible population, participated in the ophthalmological examination. A two-stage method was adopted to identify cases of glaucoma. All subjects underwent a standardized initial examination. Glaucoma suspects and 50% of non-suspects were referred to a definitive examination which included visual field testing. Patients were defined as glaucoma cases if they presented abnormal visual fields and at least one of the following: high 10P, large or asymmetric cup-to-disc ratio. In addition to typical glaucomatous visual field defects such as paracentral scotoma, nasal step, arcuate scotoma and temporal and/or central islands fields, a visual field defect was identified as a decrease in sensitivity greater than 6 db in at least one location of the central 10 degrees, two locations of the central 20 degrees or three locations of the central 30 degrees. Prevalence rates of 2.51% of Primary Open Angle Glaucoma (1.72%-3.66%, CI 95%), 0.97% of Primary Closed Angle Glaucoma (0.53%-1.77%, CI 95%) and 0.29% of secondary glaucoma were found. Moreover, 2.13% of probable POAG (1.41%-3.20%, CI 95%) and 6.00% of High Intraocular Pressure (4.71%-7.61%, CI 95%) were found. The prevalence rates of POAG found in the Ponza Ophthalmological Survey are consistent with the results of other studies. Minor differences are most likely due to the different criteria adopted in the assessment of glaucomatous visual field damage."
},
{
"source_pmid": "17102012",
"source_text": "OBJECTIVE: To determine the prevalence of glaucoma among black and white persons 73 years and older.\nDESIGN: Participants in the fourth round of a population-based study, the Salisbury Eye Evaluation, were examined. The main outcome measure was glaucoma, based on optic nerve damage and visual field loss or obvious glaucomatous optic neuropathy without an available, reliable, reproducible visual field.\nRESULTS: A total of 1250 individuals (95.9% of those eligible) participated, 1233 (98.6%) of whom agreed to screening and an eye examination. The prevalence (95% confidence interval) of open-angle glaucoma was 3.4% (0.5%-6.4%) for white individuals aged 73 and 74 years, increasing to 9.4% (7.4%-11.5%) for those 75 years and older. There was no increasing prevalence in those older than 75 years. Among black persons, the prevalence (95% confidence interval) was 5.7% (0%-11.9%) in those aged 73 and 74 years and 23.2% (17.8%-28.5%) in those 75 years and older.\nCONCLUSIONS: Many older individuals have open-angle glaucoma, and black persons 75 years and older have substantially higher rates than whites. These findings have important implications for public health initiatives, in which screening programs may be of benefit."
}
] |
20665044
|
CONCLUSIONS: Current data suggests that IVB is an effective short-term treatment for diabetic macular edema, and that its efficacy wanes after 6 weeks. More trials exploring the therapeutic role of intravitreal bevacizumab in DME need to be conducted to define the role of bevacizumab.
|
OBJECTIVE: To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME).
DESIGN: Randomized phase II clinical trial.
PARTICIPANTS: One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320.
INTERVENTIONS: Random assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22).
MAIN OUTCOME MEASURES: Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks.
RESULTS: At baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3).
CONCLUSION: These results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose. ||||| PURPOSE: To evaluate the effect of three intravitreal injections of bevacizumab (IVB) alone or combined with triamcinolone (IVT) in the first injection for treatment of refractory diabetic macular edema (DME).
METHODS: In this prospective, placebo-controlled, randomized clinical trial, 115 eyes of 101 patients with refractory DME were included. Subjects were randomly assigned to one of the three study arms: 1) three injections of IVB (1.25 mg/0.05 ml) at 6-week intervals, 2) combined IVB and IVT (1.25 mg/0.05 ml and 2 mg/0.05 ml respectively) followed by two injections of IVB at 6-week intervals, and 3) sham injection (control group). The primary outcome measure was change in central macular thickness (CMT). Secondary outcome measures were change in best-corrected logMAR visual acuity (BCVA ) and incidence of potential adverse events.
RESULTS: Central macular thickness was reduced significantly in both the IVB and IVB/IVT groups. At week 24, CMT change compared to the baseline was -95.7 microm (95% CI, -172.2 to -19.26) in the IVB group, -92.1 microm (95% CI, -154.4 to -29.7) in the IVB/IVT group, and 34.9 microm (95% CI, 7.9 to 61.9) in the control group. There was a significant difference between the IVB and control groups (P = 0.012) and between the IVB/IVT and control groups (P = 0.022). Improvement of BCVA was initiated at weeks 6 and 12 in the IVB/IVT and IVB groups respectively. In terms of BCVA change compared to the baseline at 24 weeks, the differences between the IVB and control groups (P = 0.01) and also between the IVB/IVT and control groups (P = 0.006) were significant. No significant differences were detected in the changes of CMT and BCVA between the IVB and IVB/IVT groups (P = 0.99). Anterior chamber reaction was noticed in eight (19.5%) and seven (18.9%) eyes respectively in the IVB and IVB/IVT groups the day after injection, and it resolved with no sequel. Elevation of IOP occurred in three eyes (8.1%) in the IVB/IVT group.
CONCLUSION: Three consecutive intravitreal injections of bevacizumab had a beneficial effect on refractory DME in terms of CMT reduction and BCVA improvement. Addition of triamcinolone in the first injection seemed to induce earlier visual improvement; however, it did not show any significant additive effect later during follow-up. ||||| PURPOSE: To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME).
DESIGN: Randomized 3-arm clinical trial.
PARTICIPANTS: A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment.
METHODS: The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated.
MAIN OUTCOME MEASURES: Change in best-corrected visual acuity (VA) at week 24.
RESULTS: VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes +/- standard deviation at 36 weeks were -0.28+/-0.25, -0.04+/-0.33, and +0.01+/-0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively.
CONCLUSIONS: Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article. ||||| PURPOSE: To evaluate the additive effect of triamcinolone to bevacizumab in comparison to standard macular laser photocoagulation versus bevacizumab in the management of diabetic macular edema (DME).
METHODS: In a prospective, randomized clinical trial, 130 eyes of 110 patients with type 2 diabetes with DME were included. Eligible eyes were randomly assigned to 1.25 mg intravitreal bevacizumab (42 eyes) (IVB group) or combination of 1.25 mg bevacizumab and 2 mg triamcinolone acetonide (41 eyes) (IVB+IVT group) or macular laser photocoagulation (47 eyes) (MPC). Central macular thickness (CMT) and visual acuity changes at week 6 and 16 were assessed.
RESULTS: The mean age of the patients was 57 -/+7 years. Patients were followed 16 weeks. At week 6, all the three groups showed significant reduction in CMT but the reductions for IVB and IVB+IVT were significantly more than MPC (p<0.001). At week 16, the response was not stable for IVB (p<0.001), but IVB+IVT maintained its superior status to MPC (p<0.001). At week 16, visual acuities were essentially unchanged for the two groups of MPC and IVB and improvement for IVB+IVT was marginal and at most was 0.1 log MAR. No patient developed uveitis, endophthalmitis, or thromboembolic event.
CONCLUSIONS: Single intravitreal bevacizumab or triamcinolone plus bevacizumab injection brought about significantly greater macular thickness reduction in diabetic patients in comparison to standard laser treatment. However, the response for bevacizumab alone was short-lived. Reduction in macular thickness was only marginally associated with visual acuity improvement in the triamcinolone plus bevacizumab injection group.
|
[
{
"source_pmid": "17698196",
"source_text": "OBJECTIVE: To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME).\nDESIGN: Randomized phase II clinical trial.\nPARTICIPANTS: One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320.\nINTERVENTIONS: Random assignment to 1 of 5 groups: (A) focal photocoagulation at baseline (n = 19), (B) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks (n = 22), (C) intravitreal injection of 2.5 mg of bevacizumab at baseline and 6 weeks (n = 24), (D) intravitreal injection of 1.25 mg of bevacizumab at baseline and sham injection at 6 weeks (n = 22), or (E) intravitreal injection of 1.25 mg of bevacizumab at baseline and 6 weeks with photocoagulation at 3 weeks (n = 22).\nMAIN OUTCOME MEASURES: Central subfield thickness (CST) on optical coherence tomography and best-corrected visual acuity (VA) were measured at baseline and after 3, 6, 9, 12, 18, and 24 weeks.\nRESULTS: At baseline, median CST was 411 mum and median Snellen VA equivalent was 20/50. Compared with group A, groups B and C had a greater reduction in CST at 3 weeks and about 1 line better median VA over 12 weeks. There were no meaningful differences between groups B and C in CST reduction or VA improvement. A CST reduction > 11% (reliability limit) was present at 3 weeks in 36 of 84 (43%) bevacizumab-treated eyes and 5 of 18 (28%) eyes treated with laser alone, and at 6 weeks in 31 of 84 (37%) and 9 of 18 (50%) eyes, respectively. Combining focal photocoagulation with bevacizumab resulted in no apparent short-term benefit or adverse outcomes. Endophthalmitis developed in 1 eye. The following events occurred during the first 24 weeks in subjects treated with bevacizumab without attributing cause to the drug: myocardial infarction (n = 2), congestive heart failure (n = 1), elevated blood pressure (n = 3), and worsened renal function (n = 3).\nCONCLUSION: These results demonstrate that intravitreal bevacizumab can reduce DME in some eyes, but the study was not designed to determine whether treatment is beneficial. A phase III trial would be needed for that purpose."
},
{
"source_pmid": "17917738",
"source_text": "PURPOSE: To evaluate the effect of three intravitreal injections of bevacizumab (IVB) alone or combined with triamcinolone (IVT) in the first injection for treatment of refractory diabetic macular edema (DME).\nMETHODS: In this prospective, placebo-controlled, randomized clinical trial, 115 eyes of 101 patients with refractory DME were included. Subjects were randomly assigned to one of the three study arms: 1) three injections of IVB (1.25 mg/0.05 ml) at 6-week intervals, 2) combined IVB and IVT (1.25 mg/0.05 ml and 2 mg/0.05 ml respectively) followed by two injections of IVB at 6-week intervals, and 3) sham injection (control group). The primary outcome measure was change in central macular thickness (CMT). Secondary outcome measures were change in best-corrected logMAR visual acuity (BCVA ) and incidence of potential adverse events.\nRESULTS: Central macular thickness was reduced significantly in both the IVB and IVB/IVT groups. At week 24, CMT change compared to the baseline was -95.7 microm (95% CI, -172.2 to -19.26) in the IVB group, -92.1 microm (95% CI, -154.4 to -29.7) in the IVB/IVT group, and 34.9 microm (95% CI, 7.9 to 61.9) in the control group. There was a significant difference between the IVB and control groups (P = 0.012) and between the IVB/IVT and control groups (P = 0.022). Improvement of BCVA was initiated at weeks 6 and 12 in the IVB/IVT and IVB groups respectively. In terms of BCVA change compared to the baseline at 24 weeks, the differences between the IVB and control groups (P = 0.01) and also between the IVB/IVT and control groups (P = 0.006) were significant. No significant differences were detected in the changes of CMT and BCVA between the IVB and IVB/IVT groups (P = 0.99). Anterior chamber reaction was noticed in eight (19.5%) and seven (18.9%) eyes respectively in the IVB and IVB/IVT groups the day after injection, and it resolved with no sequel. Elevation of IOP occurred in three eyes (8.1%) in the IVB/IVT group.\nCONCLUSION: Three consecutive intravitreal injections of bevacizumab had a beneficial effect on refractory DME in terms of CMT reduction and BCVA improvement. Addition of triamcinolone in the first injection seemed to induce earlier visual improvement; however, it did not show any significant additive effect later during follow-up."
},
{
"source_pmid": "19376585",
"source_text": "PURPOSE: To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME).\nDESIGN: Randomized 3-arm clinical trial.\nPARTICIPANTS: A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment.\nMETHODS: The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated.\nMAIN OUTCOME MEASURES: Change in best-corrected visual acuity (VA) at week 24.\nRESULTS: VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes +/- standard deviation at 36 weeks were -0.28+/-0.25, -0.04+/-0.33, and +0.01+/-0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively.\nCONCLUSIONS: Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated.\nFINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article."
},
{
"source_pmid": "18988166",
"source_text": "PURPOSE: To evaluate the additive effect of triamcinolone to bevacizumab in comparison to standard macular laser photocoagulation versus bevacizumab in the management of diabetic macular edema (DME).\nMETHODS: In a prospective, randomized clinical trial, 130 eyes of 110 patients with type 2 diabetes with DME were included. Eligible eyes were randomly assigned to 1.25 mg intravitreal bevacizumab (42 eyes) (IVB group) or combination of 1.25 mg bevacizumab and 2 mg triamcinolone acetonide (41 eyes) (IVB+IVT group) or macular laser photocoagulation (47 eyes) (MPC). Central macular thickness (CMT) and visual acuity changes at week 6 and 16 were assessed.\nRESULTS: The mean age of the patients was 57 -/+7 years. Patients were followed 16 weeks. At week 6, all the three groups showed significant reduction in CMT but the reductions for IVB and IVB+IVT were significantly more than MPC (p<0.001). At week 16, the response was not stable for IVB (p<0.001), but IVB+IVT maintained its superior status to MPC (p<0.001). At week 16, visual acuities were essentially unchanged for the two groups of MPC and IVB and improvement for IVB+IVT was marginal and at most was 0.1 log MAR. No patient developed uveitis, endophthalmitis, or thromboembolic event.\nCONCLUSIONS: Single intravitreal bevacizumab or triamcinolone plus bevacizumab injection brought about significantly greater macular thickness reduction in diabetic patients in comparison to standard laser treatment. However, the response for bevacizumab alone was short-lived. Reduction in macular thickness was only marginally associated with visual acuity improvement in the triamcinolone plus bevacizumab injection group."
}
] |
23741296
|
CONCLUSION: Ex-Press was associated with equivalent efficacy to Trab in lowering IOP. Comparable proportions of patients reached the IOP target with Ex-Press and Trab. Ex-Press was better tolerated than Trab.
|
INTRODUCTION: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma.
METHODS: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and <or=18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and <or=15 mmHg was also noted.
RESULTS: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and <or=15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group.
CONCLUSIONS: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma. ||||| BACKGROUND AND OBJECTIVE: To compare the success and complication rates of patients with glaucoma who had an Ex-PRESS mini glaucoma shunt device implantation (Optonol, Ltd., Neve Ilan, Israel) to those who had conventional trabeculectomy.
PATIENTS AND METHODS: The records of 76 eyes of 69 consecutive subjects who had Ex-PRESS implants and 77 eyes of 65 consecutive controls who had trabeculectomy procedures were reviewed. All surgeries were performed by one of the authors (LWH). Success was defined as an intraocular pressure (IOP) between 5 and 21 mm Hg in patients who did not require further glaucoma surgery in the eye of note.
RESULTS: The difference in the percentage of cases of postoperative hypotony between the standard trabeculectomy group (16%) and the Ex-PRESS group (4%) was statistically significant (P = .023).
CONCLUSION: The Ex-PRESS device is at least as effective as the standard trabeculectomy in lowering the IOP of patients with glaucoma, with a significantly lower risk of postoperative hypotony. The data further suggest that the Ex-PRESS device results in an overall greater percentage reduction in IOP than with trabeculectomy, although this did not reach statistical significance. ||||| BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.
METHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.
RESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.
CONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma. ||||| PURPOSE: To compare outcomes between resident-performed trabeculectomy and Ex-PRESS shunt implantation.
METHODS: A consecutive cohort of 36 Ex-PRESS shunt implantations and 57 trabeculectomies (1 eye/patient) performed by resident surgeons in their third year of ophthalmic training at the University of California, San Francisco and at the San Francisco Veterans Administration Hospital, under the supervision of a single glaucoma fellowship-trained surgeon were included in this study. Eyes with < 6 months of follow-up or previous glaucoma surgery were excluded. Preoperative and postoperative intraocular pressure (IOP), preoperative and postoperative number of ocular antihypertensive medications and complication rates were compared between the 2 procedures retrospectively.
RESULTS: No difference was found in postoperative IOP (all, P≥0.099) or proportional decrease in IOP (all, P≥0.092) between the trabeculectomy and Ex-PRESS shunt groups at all follow-up points. On average, the Ex-PRESS shunt group required significantly less ocular antihypertensive medication to control IOP at 3 months postoperative (P=0.01), but no difference was found at 6 months or 1 year (all, P≥0.28). A larger proportion of Ex-PRESS shunt patients had good IOP control without medication at 3 (P=0.057) and 6 months (P=0.076) postoperatively. No difference was found in the rates of sight-threatening complications between groups (all, P≥0.22).
CONCLUSIONS: In the hands of ophthalmology residents in their third year of training, the trabeculectomy and Ex-PRESS shunt implantation procedures perform comparably in terms of postoperative IOP control, reduction in patient dependence on ocular antihypertensive medications, and risk of complication in our population. ||||| PURPOSE: This paper compares the outcomes of the Ex-PRESS(®) Glaucoma Filtration Device (Alcon, Fort Worth, TX) implant observed in Japanese patients for 1 year with those of patients undergoing trabeculectomy.
PATIENTS AND METHODS: The subjects comprised ten eyes of ten cases with open-angle glaucoma for which filtration surgery using Ex-PRESS (P-50) was performed by one operator from February 2008 and observed for at least 1 year (Ex-PRESS Group), and eleven eyes of eleven cases for which trabeculectomy was performed by the same operator (TE Group). For both groups, mitomycin C was used and a scleral flap was created after a fornix-based incision of the conjunctiva.
RESULTS: Hypotony and choroidal detachment were observed as early postoperative complications during a 1-week period in one-third of the cases in the TE Group, and failing vision in about 45%, while these were seen in fewer cases in the Ex-PRESS Group. No significant difference in intraocular pressure (IOP) was observed during the period, but IOP variations on the day following the surgery were obviously narrower in the Ex-PRESS Group than in the TE Group. Visual acuity was significantly poorer from 1 week to 3 months in the TE Group while it was stable in the Ex-PRESS Group. The Ex-PRESS Group had fewer cases of laser suture lysis and fewer administrations of glaucoma eyedrop, and no cases of progression in the stage of visual field defect.
CONCLUSION: Filtration surgery using the Ex-PRESS is unlikely to cause early complications in Japanese patients. Similarly to the trabeculectomy, the intermediate-term control of IOP showed favorable results. ||||| PURPOSE: To evaluate postoperative outcomes and success after combined phacoemulsification and glaucoma surgery with Ex-PRESS miniature implant compared with combined surgery with standard trabeculectomy.
METHODS: In this prospective series of 40 consecutive eyes we compared 20 eyes in 17 patients treated with combined phacoemulsification and glaucoma filtering surgery with the Ex-PRESS miniature glaucoma implant under a scleral flap with 20 matched control eyes in 20 patients who underwent combined cataract and glaucoma surgery with trabeculectomy.
RESULTS: The average follow-up was 9.7 months (range 4.5 to 15) for the Ex-PRESS group and 10.3 months (range 3.5 to 14.5) for the trabeculectomy group. The mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group. Complications rate in the early postoperative period was significantly higher in the trabeculectomy group. No significant differences were objectified in success between both groups after the first week.
DISCUSSION: The Ex-PRESS implant is an effective and safe alternative to standard trabeculectomy in selected cases which makes possible to reduce remarkably the classic early postoperative complications associated with trabeculectomy. ||||| PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).
DESIGN: Prospective, randomised study.
PATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.
RESULTS: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.
CONCLUSIONS: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications. ||||| PURPOSE: To evaluate the Ex-PRESS miniature implant (Model R 50) placed under partial-thickness scleral flap compared with standard trabeculectomy.
METHODS: In this retrospective comparative series of 100 eyes, we compared 50 eyes in 49 patients treated with the Ex-PRESS miniature glaucoma implant under a scleral flap with 50 matched control eyes in 47 patients treated with trabeculectomy. Success was defined as intraocular pressure (IOP) > or =5 mm Hg and < or =21 mm Hg, with or without glaucoma medications, without further glaucoma surgery or removal of implant. Early postoperative hypotony was defined as IOP <5 mm Hg during the first postoperative week.
RESULTS: The average follow-up was 10.8 months (range 3.5 to 18) for the Ex-PRESS group and 11.2 months (range 3 to 15) for the trabeculectomy group. Although the mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group, the reduction of IOP was similar in both groups after 3 months. The number of postoperative glaucoma medications in both groups was not significantly different. Kaplan-Meier survival curve analysis showed no significant difference in success between the 2 groups (P=0.594). Early postoperative hypotony and choroidal effusion were significantly more frequent after trabeculectomy compared with Ex-PRESS implant under scleral flap (P<0.001).
CONCLUSIONS: The Ex-PRESS implant under a scleral flap had similar IOP-lowering efficacy with a lower rate of early hypotony compared with trabeculectomy.
|
[
{
"source_pmid": "19337705",
"source_text": "INTRODUCTION: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma.\nMETHODS: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and <or=18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and <or=15 mmHg was also noted.\nRESULTS: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and <or=15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group.\nCONCLUSIONS: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma."
},
{
"source_pmid": "22074705",
"source_text": "BACKGROUND AND OBJECTIVE: To compare the success and complication rates of patients with glaucoma who had an Ex-PRESS mini glaucoma shunt device implantation (Optonol, Ltd., Neve Ilan, Israel) to those who had conventional trabeculectomy.\nPATIENTS AND METHODS: The records of 76 eyes of 69 consecutive subjects who had Ex-PRESS implants and 77 eyes of 65 consecutive controls who had trabeculectomy procedures were reviewed. All surgeries were performed by one of the authors (LWH). Success was defined as an intraocular pressure (IOP) between 5 and 21 mm Hg in patients who did not require further glaucoma surgery in the eye of note.\nRESULTS: The difference in the percentage of cases of postoperative hypotony between the standard trabeculectomy group (16%) and the Ex-PRESS group (4%) was statistically significant (P = .023).\nCONCLUSION: The Ex-PRESS device is at least as effective as the standard trabeculectomy in lowering the IOP of patients with glaucoma, with a significantly lower risk of postoperative hypotony. The data further suggest that the Ex-PRESS device results in an overall greater percentage reduction in IOP than with trabeculectomy, although this did not reach statistical significance."
},
{
"source_pmid": "21607021",
"source_text": "BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.\nMETHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.\nRESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.\nCONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma."
},
{
"source_pmid": "21522022",
"source_text": "PURPOSE: To compare outcomes between resident-performed trabeculectomy and Ex-PRESS shunt implantation.\nMETHODS: A consecutive cohort of 36 Ex-PRESS shunt implantations and 57 trabeculectomies (1 eye/patient) performed by resident surgeons in their third year of ophthalmic training at the University of California, San Francisco and at the San Francisco Veterans Administration Hospital, under the supervision of a single glaucoma fellowship-trained surgeon were included in this study. Eyes with < 6 months of follow-up or previous glaucoma surgery were excluded. Preoperative and postoperative intraocular pressure (IOP), preoperative and postoperative number of ocular antihypertensive medications and complication rates were compared between the 2 procedures retrospectively.\nRESULTS: No difference was found in postoperative IOP (all, P≥0.099) or proportional decrease in IOP (all, P≥0.092) between the trabeculectomy and Ex-PRESS shunt groups at all follow-up points. On average, the Ex-PRESS shunt group required significantly less ocular antihypertensive medication to control IOP at 3 months postoperative (P=0.01), but no difference was found at 6 months or 1 year (all, P≥0.28). A larger proportion of Ex-PRESS shunt patients had good IOP control without medication at 3 (P=0.057) and 6 months (P=0.076) postoperatively. No difference was found in the rates of sight-threatening complications between groups (all, P≥0.22).\nCONCLUSIONS: In the hands of ophthalmology residents in their third year of training, the trabeculectomy and Ex-PRESS shunt implantation procedures perform comparably in terms of postoperative IOP control, reduction in patient dependence on ocular antihypertensive medications, and risk of complication in our population."
},
{
"source_pmid": "21847337",
"source_text": "PURPOSE: This paper compares the outcomes of the Ex-PRESS(®) Glaucoma Filtration Device (Alcon, Fort Worth, TX) implant observed in Japanese patients for 1 year with those of patients undergoing trabeculectomy.\nPATIENTS AND METHODS: The subjects comprised ten eyes of ten cases with open-angle glaucoma for which filtration surgery using Ex-PRESS (P-50) was performed by one operator from February 2008 and observed for at least 1 year (Ex-PRESS Group), and eleven eyes of eleven cases for which trabeculectomy was performed by the same operator (TE Group). For both groups, mitomycin C was used and a scleral flap was created after a fornix-based incision of the conjunctiva.\nRESULTS: Hypotony and choroidal detachment were observed as early postoperative complications during a 1-week period in one-third of the cases in the TE Group, and failing vision in about 45%, while these were seen in fewer cases in the Ex-PRESS Group. No significant difference in intraocular pressure (IOP) was observed during the period, but IOP variations on the day following the surgery were obviously narrower in the Ex-PRESS Group than in the TE Group. Visual acuity was significantly poorer from 1 week to 3 months in the TE Group while it was stable in the Ex-PRESS Group. The Ex-PRESS Group had fewer cases of laser suture lysis and fewer administrations of glaucoma eyedrop, and no cases of progression in the stage of visual field defect.\nCONCLUSION: Filtration surgery using the Ex-PRESS is unlikely to cause early complications in Japanese patients. Similarly to the trabeculectomy, the intermediate-term control of IOP showed favorable results."
},
{
"source_pmid": "19568989",
"source_text": "PURPOSE: To evaluate postoperative outcomes and success after combined phacoemulsification and glaucoma surgery with Ex-PRESS miniature implant compared with combined surgery with standard trabeculectomy.\nMETHODS: In this prospective series of 40 consecutive eyes we compared 20 eyes in 17 patients treated with combined phacoemulsification and glaucoma filtering surgery with the Ex-PRESS miniature glaucoma implant under a scleral flap with 20 matched control eyes in 20 patients who underwent combined cataract and glaucoma surgery with trabeculectomy.\nRESULTS: The average follow-up was 9.7 months (range 4.5 to 15) for the Ex-PRESS group and 10.3 months (range 3.5 to 14.5) for the trabeculectomy group. The mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group. Complications rate in the early postoperative period was significantly higher in the trabeculectomy group. No significant differences were objectified in success between both groups after the first week.\nDISCUSSION: The Ex-PRESS implant is an effective and safe alternative to standard trabeculectomy in selected cases which makes possible to reduce remarkably the classic early postoperative complications associated with trabeculectomy."
},
{
"source_pmid": "22344189",
"source_text": "PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).\nDESIGN: Prospective, randomised study.\nPATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.\nRESULTS: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.\nCONCLUSIONS: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications."
},
{
"source_pmid": "17224744",
"source_text": "PURPOSE: To evaluate the Ex-PRESS miniature implant (Model R 50) placed under partial-thickness scleral flap compared with standard trabeculectomy.\nMETHODS: In this retrospective comparative series of 100 eyes, we compared 50 eyes in 49 patients treated with the Ex-PRESS miniature glaucoma implant under a scleral flap with 50 matched control eyes in 47 patients treated with trabeculectomy. Success was defined as intraocular pressure (IOP) > or =5 mm Hg and < or =21 mm Hg, with or without glaucoma medications, without further glaucoma surgery or removal of implant. Early postoperative hypotony was defined as IOP <5 mm Hg during the first postoperative week.\nRESULTS: The average follow-up was 10.8 months (range 3.5 to 18) for the Ex-PRESS group and 11.2 months (range 3 to 15) for the trabeculectomy group. Although the mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group, the reduction of IOP was similar in both groups after 3 months. The number of postoperative glaucoma medications in both groups was not significantly different. Kaplan-Meier survival curve analysis showed no significant difference in success between the 2 groups (P=0.594). Early postoperative hypotony and choroidal effusion were significantly more frequent after trabeculectomy compared with Ex-PRESS implant under scleral flap (P<0.001).\nCONCLUSIONS: The Ex-PRESS implant under a scleral flap had similar IOP-lowering efficacy with a lower rate of early hypotony compared with trabeculectomy."
}
] |
27846316
|
CONCLUSION: The current literature suggests a possible association between GC use and the development of cataract. However, this risk cannot be accurately quantified in RA from the available evidence. RCTs have not adequately captured these outcomes and well-designed observational research is required.
|
OBJECTIVE: To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis (RA) receiving standardized disease-modifying antirheumatic drug (DMARD) therapy.
METHODS: Patients with active RA of <2 years' duration were randomly assigned in a double-blinded manner to receive prednisolone or placebo while starting concomitant DMARD therapy (gold sodium thiomalate or methotrexate). Hand and foot radiographs were taken at baseline and at 6, 12, and 24 months and were evaluated according to the Ratingen score and the total modified Sharp/van der Heijde score (SHS).
RESULTS: Of 192 included patients, 166 were available for the intent-to-treat analysis (ITT). Seventy-six patients completed the study per protocol (PP). Radiographic progression (increase in the Ratingen score) was significantly less with prednisolone than with placebo. The difference in the progression rate between the groups was greatest in the first 6 months. At 24 months in the ITT population, the least squares (LS) mean difference was 3.14 (95% confidence interval [95% CI] 0.94, 5.34), P = 0.006. The results were confirmed by the total SHS in the ITT population (LS mean difference 7.20 [95% CI 0.93, 13.47], P = 0.022) and with the PP population. Clinical and functional outcomes tended to be better and the rate of remissions was higher in the prednisolone group. Side effects were observed more frequently in the prednisolone group than in the control group: weight gain (4 versus 0 patients), hypertension (6 versus 2 patients), glaucoma (3 versus 0 patients), Cushing's syndrome (5 versus 0 patients), gastric distress (9 versus 4 patients), and gastric ulcers (only with concomitant nonsteroidal antiinflammatory drug therapy; 3 versus 0 patients). No new lumbar fractures were found in either group.
CONCLUSION: The very low daily dose of 5 mg prednisolone given over 2 years in combination with background DMARD therapy substantially decreased radiographic progression in early RA at low risk. ||||| BACKGROUND: Oral glucocorticoids combined with disease-modifying antirheumatic drugs are beneficial and retard radiologic joint damage in rheumatoid arthritis.
OBJECTIVE: To investigate the clinical efficacy, disease-modifying properties, and side effects of low-dose glucocorticoids as monotherapy for previously untreated patients with early active rheumatoid arthritis.
DESIGN: 2-year randomized, double-blind, placebo-controlled clinical trial.
SETTING: 2 outpatient rheumatology clinics.
PATIENTS: 81 patients with early active rheumatoid arthritis who had not been treated with disease-modifying antirheumatic drugs.
INTERVENTION: 41 patients were assigned to 10 mg of oral prednisone per day, and 40 were assigned to placebo. Nonsteroidal anti-inflammatory drugs were allowed in both groups. After 6 months, sulfasalazine (2 g/d) could be prescribed as rescue medication.
MEASUREMENTS: Clinical variables were assessed at baseline and every 3 months; radiologic studies were performed every 6 months. Adverse effects were documented every 3 months.
RESULTS: In the first 6 months, the prednisone group showed more clinical improvement than the placebo group. This effect was not seen after 6 months except in grip strength and the 28-joint score for tenderness. Use of additional therapies was significantly less common in the prednisone group, particularly in the first 6 months. More than 65% of those who completed the study were not taking sulfasalazine. After month 6, radiologic scores showed significantly less progression in the prednisone group than in the placebo group. No clinically relevant adverse effects were observed, except for a higher incidence of osteoporotic fractures in the prednisone group.
CONCLUSIONS: Prednisone, 10 mg/d, provides clinical benefit, particularly in the first 6 months, and substantially inhibits progression of radiologic joint damage in patients with early active rheumatoid arthritis and no previous treatment with disease-modifying antirheumatic drugs. Because of their limited disease-modifying effects, glucocorticoids should be combined with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. ||||| BACKGROUND: Treatment strategies for tight control of early rheumatoid arthritis (RA) are highly effective but can be improved.
OBJECTIVE: To investigate whether adding prednisone, 10 mg/d, at the start of a methotrexate (MTX)-based treatment strategy for tight control in early RA increases its effectiveness.
DESIGN: A 2-year, prospective, randomized, placebo-controlled, double-blind, multicenter trial (CAMERA-II [Computer Assisted Management in Early Rheumatoid Arthritis trial-II]). (International Standard Randomised Controlled Trial Number: ISRCTN 70365169)
SETTING: 7 hospitals in the Netherlands.
PATIENTS: 236 patients with early RA (duration <1 year).
INTERVENTION: Patients were randomly assigned to an MTX-based, tight control strategy starting with either MTX and prednisone or MTX and placebo. Methotrexate treatment was tailored to the individual patient at monthly visits on the basis of predefined response criteria aiming for remission.
MEASUREMENTS: The primary outcome was radiographic erosive joint damage after 2 years. Secondary outcomes included response criteria, remission, and the need to add cyclosporine or a biologic agent to the treatment.
RESULTS: Erosive joint damage after 2 years was limited and less in the group receiving MTX and prednisone (n = 117) than in the group receiving MTX and placebo (n = 119). The MTX and prednisone strategy was also more effective in reducing disease activity and physical disability, achieving sustained remission, and avoiding the addition of cyclosporine or biologic treatment. Adverse events were similar in both groups, but some occurred less in the MTX and prednisone group.
LIMITATION: A tight control strategy for RA implies monthly visits to an outpatient clinic, which is not always feasible.
CONCLUSION: Inclusion of low-dose prednisone in an MTX-based treatment strategy for tight control in early RA improves patient outcomes.
PRIMARY FUNDING SOURCE: Catharijne Foundation.
|
[
{
"source_pmid": "16255011",
"source_text": "OBJECTIVE: To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis (RA) receiving standardized disease-modifying antirheumatic drug (DMARD) therapy.\nMETHODS: Patients with active RA of <2 years' duration were randomly assigned in a double-blinded manner to receive prednisolone or placebo while starting concomitant DMARD therapy (gold sodium thiomalate or methotrexate). Hand and foot radiographs were taken at baseline and at 6, 12, and 24 months and were evaluated according to the Ratingen score and the total modified Sharp/van der Heijde score (SHS).\nRESULTS: Of 192 included patients, 166 were available for the intent-to-treat analysis (ITT). Seventy-six patients completed the study per protocol (PP). Radiographic progression (increase in the Ratingen score) was significantly less with prednisolone than with placebo. The difference in the progression rate between the groups was greatest in the first 6 months. At 24 months in the ITT population, the least squares (LS) mean difference was 3.14 (95% confidence interval [95% CI] 0.94, 5.34), P = 0.006. The results were confirmed by the total SHS in the ITT population (LS mean difference 7.20 [95% CI 0.93, 13.47], P = 0.022) and with the PP population. Clinical and functional outcomes tended to be better and the rate of remissions was higher in the prednisolone group. Side effects were observed more frequently in the prednisolone group than in the control group: weight gain (4 versus 0 patients), hypertension (6 versus 2 patients), glaucoma (3 versus 0 patients), Cushing's syndrome (5 versus 0 patients), gastric distress (9 versus 4 patients), and gastric ulcers (only with concomitant nonsteroidal antiinflammatory drug therapy; 3 versus 0 patients). No new lumbar fractures were found in either group.\nCONCLUSION: The very low daily dose of 5 mg prednisolone given over 2 years in combination with background DMARD therapy substantially decreased radiographic progression in early RA at low risk."
},
{
"source_pmid": "11777359",
"source_text": "BACKGROUND: Oral glucocorticoids combined with disease-modifying antirheumatic drugs are beneficial and retard radiologic joint damage in rheumatoid arthritis.\nOBJECTIVE: To investigate the clinical efficacy, disease-modifying properties, and side effects of low-dose glucocorticoids as monotherapy for previously untreated patients with early active rheumatoid arthritis.\nDESIGN: 2-year randomized, double-blind, placebo-controlled clinical trial.\nSETTING: 2 outpatient rheumatology clinics.\nPATIENTS: 81 patients with early active rheumatoid arthritis who had not been treated with disease-modifying antirheumatic drugs.\nINTERVENTION: 41 patients were assigned to 10 mg of oral prednisone per day, and 40 were assigned to placebo. Nonsteroidal anti-inflammatory drugs were allowed in both groups. After 6 months, sulfasalazine (2 g/d) could be prescribed as rescue medication.\nMEASUREMENTS: Clinical variables were assessed at baseline and every 3 months; radiologic studies were performed every 6 months. Adverse effects were documented every 3 months.\nRESULTS: In the first 6 months, the prednisone group showed more clinical improvement than the placebo group. This effect was not seen after 6 months except in grip strength and the 28-joint score for tenderness. Use of additional therapies was significantly less common in the prednisone group, particularly in the first 6 months. More than 65% of those who completed the study were not taking sulfasalazine. After month 6, radiologic scores showed significantly less progression in the prednisone group than in the placebo group. No clinically relevant adverse effects were observed, except for a higher incidence of osteoporotic fractures in the prednisone group.\nCONCLUSIONS: Prednisone, 10 mg/d, provides clinical benefit, particularly in the first 6 months, and substantially inhibits progression of radiologic joint damage in patients with early active rheumatoid arthritis and no previous treatment with disease-modifying antirheumatic drugs. Because of their limited disease-modifying effects, glucocorticoids should be combined with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis."
},
{
"source_pmid": "22393128",
"source_text": "BACKGROUND: Treatment strategies for tight control of early rheumatoid arthritis (RA) are highly effective but can be improved.\nOBJECTIVE: To investigate whether adding prednisone, 10 mg/d, at the start of a methotrexate (MTX)-based treatment strategy for tight control in early RA increases its effectiveness.\nDESIGN: A 2-year, prospective, randomized, placebo-controlled, double-blind, multicenter trial (CAMERA-II [Computer Assisted Management in Early Rheumatoid Arthritis trial-II]). (International Standard Randomised Controlled Trial Number: ISRCTN 70365169)\nSETTING: 7 hospitals in the Netherlands.\nPATIENTS: 236 patients with early RA (duration <1 year).\nINTERVENTION: Patients were randomly assigned to an MTX-based, tight control strategy starting with either MTX and prednisone or MTX and placebo. Methotrexate treatment was tailored to the individual patient at monthly visits on the basis of predefined response criteria aiming for remission.\nMEASUREMENTS: The primary outcome was radiographic erosive joint damage after 2 years. Secondary outcomes included response criteria, remission, and the need to add cyclosporine or a biologic agent to the treatment.\nRESULTS: Erosive joint damage after 2 years was limited and less in the group receiving MTX and prednisone (n = 117) than in the group receiving MTX and placebo (n = 119). The MTX and prednisone strategy was also more effective in reducing disease activity and physical disability, achieving sustained remission, and avoiding the addition of cyclosporine or biologic treatment. Adverse events were similar in both groups, but some occurred less in the MTX and prednisone group.\nLIMITATION: A tight control strategy for RA implies monthly visits to an outpatient clinic, which is not always feasible.\nCONCLUSION: Inclusion of low-dose prednisone in an MTX-based treatment strategy for tight control in early RA improves patient outcomes.\nPRIMARY FUNDING SOURCE: Catharijne Foundation."
}
] |
30030923
|
This meta-analysis strongly suggests improved VA outcomes at 12 months in patients with wet AMD for 2.0 mg aflibercept, comparable to but slightly lower than landmark trials. Increased injection frequency and younger age demonstrates a trend with improved outcomes.
|
PURPOSE: To study visual outcome and number of annual injections in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) before and after a change in first-line therapy from ranibizumab to aflibercept in a high-volume clinical practice.
METHODS: This was a retrospective chart review of routine clinical practice. The study included 1027 treatment-naïve patients, 559 of whom started intravitreal ranibizumab therapy in 2011-2012 and 468 of whom started intravitreal aflibercept therapy in 2013-2014, a fixed loading dose of three injections followed by a pro re nata treatment regimen used in both periods.
RESULTS: Snellen best-corrected visual acuity (BCVA) at baseline and after one year was 0.23 and 0.31 (p < 0.0001), respectively, for patients treated with ranibizumab and 0.25 and 0.33 (p < 0.0001) for patients treated with aflibercept, last observation carried forward. The share of patients (73%) still in treatment with ranibizumab at year 1 had a baseline BCVA of 0.26 but 0.40 at year 1 (p < 0.0001), and the patients (75%) still in treatment with aflibercept at year 1 had a baseline BCVA of 0.28 but 0.42 at year 1 (p < 0.0001). Proportional visual gains for both cohorts were comparable for one year (p = 0.14). The number of injections given within year 1 including first injection was 6.9 for ranibizumab and 5.9 for aflibercept (p < 0.0001). In patients continuing treatment through year 1, the number of injections was 8.0 for ranibizumab and 6.6 for aflibercept (p < 0.0001). The two cohorts had similar cause-of-discontinuation profiles.
CONCLUSION: Treatment of nAMD at a single centre in two sequential cohorts yielded comparable BCVA outcomes with 15% fewer injections of aflibercept compared to ranibizumab. ||||| OBJECTIVE: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.
DESIGN: Double-masked, multicenter, parallel-group, active-controlled, randomized trials.
PARTICIPANTS: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD.
INTERVENTION: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4).
MAIN OUTCOME MEASURES: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures.
RESULTS: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups.
CONCLUSIONS: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references. ||||| PURPOSE: To evaluate a modified treat-and-extend (TAE) regimen of intravitreal aflibercept injection (IAI) for treatment-naïve patients with neovascular age-related macular degeneration (AMD).
METHODS: Thirty-six eyes (36 patients) treated with the modified TAE regimen were evaluated at 12 months retrospectively. The modified TAE regimen consisted of three steps: 1) an induction phase, during which patients were treated with ≥ 3-monthly IAIs until exudative activity disappeared, 2) an observation phase, during which patients were monitored until exudative activity appeared, and 3) a TAE phase, for which the initial treatment interval was determined based on the disease recurrence interval, followed by treatment intervals changing by 2 weeks.
RESULTS: Mean logMAR BCVA improved significantly from 0.48 ± 0.51 at baseline to 0.40 ± 0.53 at 12 months (P < 0.01), and was maintained (losing <0.3 logMAR units) in 35 eyes (97.2 %). Mean central retinal thickness and central choroidal thickness decreased significantly after 12 months. In the TAE phase, the distribution of treatment intervals was ≥8 weeks in 64.7 % (11 eyes) at 12 months. The mean number of injections was 4.53.
CONCLUSION: A modified TAE regimen of IAI for neovascular AMD produced good functional outcomes over 12 months with the small number of injections. ||||| PURPOSE: We compared 1-year outcomes of 1 + pro re nata (PRN) versus 3 + PRN of intravitreal aflibercept injection (IAI) for age-related macular degeneration (AMD).
METHODS: Forty-two eyes with naïve AMD received 3 + PRN IAI treatment and 47 eyes with naïve AMD received 1 + PRN IAI treatment. Visual acuity (VA), central retinal thickness (CRT), and central choroidal thickness (CCT) and number of administered IAIs during 12 months were compared.
RESULTS: VAs improved, and CRTs reduced significantly at any given month from baseline in both groups (p < 0.01, respectively). CCT reduced significantly at 3 months in the 3 + PRN group (p = 0.024) but not in the 1 + PRN group. The 1 + PRN group received fewer injections than the 3 + PRN group (p < 0.01).
CONCLUSIONS: Aflibercept leads to equivalent VA and morphologic retinal improvement without administering 3 injections. ||||| PURPOSE: Aflibercept has the potential advantage of reducing capacity problems by allowing 2 monthly visits for patients with neovascular macular degeneration (nAMD) compared with monthly pro re nata regimens that are the most commonly used in the United Kingdom. This study aimed to report the visual outcomes achieved in routine clinical practice using the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) protocol at 1 year and compare with trials data and other real-world reports.
DESIGN: Retrospective data analysis from an electronic medical record.
PARTICIPANTS: Consecutive series of treatment-naïve patients initiated on aflibercept for nAMD at least 1 year before data extraction.
METHODS: Data were anonymized and remotely extracted from 16 centers in the United Kingdom that use the same electronic medical record (EMR) system (Medisoft Ophthalmology; Medisoft Limited, Leeds, UK).
MAIN OUTCOME MEASURES: The minimum data set defined before first data entry and mandated by the EMR included age, gender, visual acuity, injection episodes, and complications.
RESULTS: The mean age was 80.0 years (median, 81.0 years) and 63.7% were women. During the first year of treatment with aflibercept, 1840 treatment-naïve eyes of 1682 patients received a median of 8 (mean, 7.0) injections at a median of 8 (mean, 7.3) visits. The mean baseline visual acuity was 53.7 letters, improving to 58.8 letters (+5.1-letter gain) at 1 year. In first-treated eyes, the respective figures were 52.7 letters at baseline and 58.2 letters at 1 year, a gain of +5.5 letters. The proportion achieving 70 letters or more increased from 16.4% at baseline to 33.7% at 1 year, and 92% avoided moderate visual loss at 1 year.
CONCLUSIONS: The visual acuity outcomes are comparable to randomized trials and better than many previous real-world data collections, with a mean +5.1-letter gain at 1 year compared with +8.4 letters in the integrated analysis of the VIEW 1 and VIEW 2 studies. Early visual gains were maintained through the year. Collection of outcomes beyond clinical trials can have limitations but better reflect the full pool of patients actually treated and are important to determine whether a particular treatment is performing as expected. Such data also have the potential to improve services by setting up a mechanism to compare sites. ||||| PURPOSE: To compare the responses of intravitreal injections of bevacizumab, ranibizumab, or aflibercept for the treatment of neovascular age-related macular degeneration (nAMD).
METHODS: This retrospective study examined 232 eyes of 232 patients who received intravitreal anti-vascular endothelial growth factor (VEGF) injections due to treatment-naïve nAMD. All patients, who were followed-up for at least 1 year, were treated with intravitreal injections monthly until 3 months, and then as needed. We evaluated the effects of intravitreal injections for treatment of nAMD using the central macular thickness (CMT), subretinal fluid (SRF), pigment epithelial detachment (PED) size, and best-corrected visual acuity (BCVA).
RESULTS: CMT, SRF, PED size, and BCVA (LogMAR) were significantly decreased after treatment with all three anti-VEGF agents. Overall, the bevacizumab, ranibizumab, and aflibercept treatments showed no significant differences in their responses. However, the aflibercept injections decreased PED size more quickly than bevacizumab injections (P = 0.034).
CONCLUSIONS: Bevacizumab, ranibizumab, and aflibercept injections are effective treatments for nAMD and have similar responses, although the number of injections of aflibercept was fewer than other anti-VEGF agents. In addition, aflibercept injections may be a better choice than other anti-VEGF agents for cases of severe increases in PED height. ||||| PURPOSE: To directly compare visual acuity (VA) outcomes with ranibizumab vs. aflibercept for eyes with neovascular age-related macular degeneration (nAMD) treated in routine clinical practice.
DESIGN: Database observational study.
PARTICIPANTS: Treatment-naïve eyes with nAMD tracked by the Fight Retinal Blindness outcome registry that commenced anti-vascular endothelial growth factor therapy with ranibizumab or aflibercept between December 1, 2013, and January 31, 2015. Eyes were matched at baseline for VA, age, and choroidal neovascular membrane (CNV) size.
METHODS: Locally weighted scatterplot smoothing curves were used to display VA results. Eyes that switched or discontinued treatment were included with their last observation carried forward.
MAIN OUTCOME MEASURES: Change in mean VA (number of letters read on a logarithm of the minimum angle of resolution chart); number of injections and visits; proportion of eyes with inactive CNV over 12 months.
RESULTS: We identified 394 eyes (197 treated with ranibizumab and 197 with aflibercept) from 372 patients who received treatment from 34 practitioners. Baseline parameters were well matched. The mean (standard deviation [SD]) VA of ranibizumab-treated eyes increased from 58.6 (20.3) letters at baseline to 62.3 (23.9) (+3.7 [95% confidence interval {CI} 1.4-6.1]) letters (P = 0.001), compared with 58.9 (19.2) letters at baseline to 63.1 (21.5) (+4.26 [95% CI 2.0-6.5]) letters (P < 0.001) for eyes receiving aflibercept. The difference in change in crude VA of 0.6 letters between the 2 groups was not statistically significant (P = 0.76), nor was the difference in adjusted mean VA of the 2 groups (P = 0.26). In completers, the mean (SD) numbers of injections (8.1 [2.1] vs. 8.0 [2.3]; P = 0.27) and visits (9.6 [3.0] vs. 9.5 [3.1]; P = 0.15) did not differ between the 2 groups. The adjusted proportion of eyes in which the CNV lesion was graded as inactive during the study was similar between the eyes receiving ranibizumab and aflibercept (74% vs. 77%, respectively; P = 0.63).
CONCLUSIONS: Visual acuity outcomes at 12 months did not differ between ranibizumab and aflibercept used for nAMD in this large observational study, nor was a difference in treatment frequency found. ||||| PURPOSE: To report 2-year treatment outcomes with intravitreal aflibercept for neovascular age-related macular degeneration (nAMD) in routine clinical practice.
DESIGN: Retrospective, nonrandomized, interventional case series.
METHODS: Retrospective analysis of electronic medical record (EMR) notes (OpenEyes) and paper case notes and review of spectral-domain optical coherence tomography (SDOCT) imaging of patients with consecutively treated eyes with previously untreated nAMD. Patients were commenced on aflibercept injections in 1 or both eyes from October 1, 2013 to December 31, 2013. Data including age, sex, visual acuity (VA) measured on Early Treatment Diabetic Retinopathy Study charts, injection episodes, and complications were recorded. Additionally, SDOCT data, including presence or absence of macular fluid and automated central subfield macular thickness (CSMT) at year 1 and 2, were recorded.
RESULTS: Of the 109 eyes of 102 patients treated, data from 94 eyes of 88 patients were available at 2-year follow-up (86% of patients). In the analysis of 2-year outcomes, there were 58 women (65.9%); the mean (± standard deviation) age was 77.5 ± 8 years. Over the 2 years, these eyes received a median of 12 (mean, 11.4 ± 4) injections at a median of 100 (mean, 99.3 ± 5.3) weeks of follow-up. The mean VA changed from 55.9 ± 15 letters at baseline to 61.3 ± 16.9 letters (VA gain 5.4 letters) at 1 year and to 61 ± 17.1 letters (VA gain 5.1 ± 14.9 letters) at 2 years. The reduction in CSMT was 79 μm with absence of macular fluid in 72.7% of the 88 eyes with SDOCT data available at 2-year follow-up.
CONCLUSIONS: The VA and SDOCT results compare favorably with outcomes seen in randomized controlled trials. The results suggest that good long-term outcomes can be achieved using aflibercept for nAMD in clinical settings. ||||| PURPOSE: To compare the 12-month treatment outcome of ranibizumab with that of aflibercept in cases of neovascular age-related macular degeneration (AMD).
METHODS: This retrospective single-institution study included patients who had been diagnosed with treatment-naïve neovascular AMD and treated using either ranibizumab (ranibizumab group, n = 30) or aflibercept (aflibercept group, n = 21) monotherapy over a 12-month follow-up period. Patients initially received three monthly injections, and were re-treated when neovascularization recurred. The best-corrected visual acuity (BCVA) at diagnosis and at 12 months, as well as the number of injections, were compared between the two groups.
RESULTS: In the ranibizumab group, the mean logarithm of the minimum angle of resolution BCVA values at diagnosis and at 12 months were 0.86 ± 0.45 and 0.72 ± 0.56, respectively. The equivalent values were 0.73 ± 0.37 and 0.58 ± 0.41 in the aflibercept group. The mean number of injections was 4.5 ± 1.3 in the ranibizumab group and 4.3 ± 0.9 in the aflibercept group. There was no difference in BCVA between the two groups at either diagnosis (P = 0.560) or 12 months (P = 0.702). There was also no difference between the two groups in the number of injections (P = 0.847).
CONCLUSION: The 12-month treatment outcome of intravitreal ranibizumab was similar to that of intravitreal aflibercept, with a comparable injection frequency. Further prospective studies with a more controlled design are needed to confirm our findings. ||||| PURPOSE: To investigate the efficacy of periodic injection of aflibercept in each subtype of age-related macular degeneration (AMD) and to explore the predictive factors for visual outcome in clinical settings.
DESIGN: Prospective nonrandomized interventional case series.
METHODS: Patients with AMD were recruited and were administered aflibercept injections once a month for 3 months followed by once every 2 months for 8 months. The logarithm of the minimal angle of resolution (logMAR) at 12 months and improvement of vision from baseline were compared among polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), and typical AMD. Regression rate of polypoidal lesions was assessed. We also performed regression analysis with logMAR at 12 months as the dependent variable.
RESULTS: The study sample consisted of 98 patients: 46 had typical AMD, 42 had PCV, and 10 had RAP. Mean logMAR improved from 0.36 to 0.21 in 12 months. While there was no difference in visual improvement between typical AMD and PCV, final logMAR was better in PCV (0.32 ± 0.09 vs 0.08 ± 0.04, P = .016). Thirty-nine PCV patients underwent follow-up angiography, and regression of polyps was observed in 27 cases (69.2%). Multiple regression analysis showed that the presence of external limiting membrane (ELM), smaller greatest linear dimension, and the presence of polypoidal lesion were associated with better visual outcome (R(2) = 0.53, P = 2.73 × 10(-14)).
CONCLUSIONS: Periodic injection of aflibercept is effective for PCV as well as for typical AMD. The statuses of ELM, greatest linear dimension, and polypoidal lesion are predictive for visual outcome.
|
[
{
"source_pmid": "27535819",
"source_text": "PURPOSE: To study visual outcome and number of annual injections in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) before and after a change in first-line therapy from ranibizumab to aflibercept in a high-volume clinical practice.\nMETHODS: This was a retrospective chart review of routine clinical practice. The study included 1027 treatment-naïve patients, 559 of whom started intravitreal ranibizumab therapy in 2011-2012 and 468 of whom started intravitreal aflibercept therapy in 2013-2014, a fixed loading dose of three injections followed by a pro re nata treatment regimen used in both periods.\nRESULTS: Snellen best-corrected visual acuity (BCVA) at baseline and after one year was 0.23 and 0.31 (p < 0.0001), respectively, for patients treated with ranibizumab and 0.25 and 0.33 (p < 0.0001) for patients treated with aflibercept, last observation carried forward. The share of patients (73%) still in treatment with ranibizumab at year 1 had a baseline BCVA of 0.26 but 0.40 at year 1 (p < 0.0001), and the patients (75%) still in treatment with aflibercept at year 1 had a baseline BCVA of 0.28 but 0.42 at year 1 (p < 0.0001). Proportional visual gains for both cohorts were comparable for one year (p = 0.14). The number of injections given within year 1 including first injection was 6.9 for ranibizumab and 5.9 for aflibercept (p < 0.0001). In patients continuing treatment through year 1, the number of injections was 8.0 for ranibizumab and 6.6 for aflibercept (p < 0.0001). The two cohorts had similar cause-of-discontinuation profiles.\nCONCLUSION: Treatment of nAMD at a single centre in two sequential cohorts yielded comparable BCVA outcomes with 15% fewer injections of aflibercept compared to ranibizumab."
},
{
"source_pmid": "23084240",
"source_text": "OBJECTIVE: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.\nDESIGN: Double-masked, multicenter, parallel-group, active-controlled, randomized trials.\nPARTICIPANTS: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD.\nINTERVENTION: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4).\nMAIN OUTCOME MEASURES: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures.\nRESULTS: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups.\nCONCLUSIONS: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring.\nFINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references."
},
{
"source_pmid": "27743159",
"source_text": "PURPOSE: To evaluate a modified treat-and-extend (TAE) regimen of intravitreal aflibercept injection (IAI) for treatment-naïve patients with neovascular age-related macular degeneration (AMD).\nMETHODS: Thirty-six eyes (36 patients) treated with the modified TAE regimen were evaluated at 12 months retrospectively. The modified TAE regimen consisted of three steps: 1) an induction phase, during which patients were treated with ≥ 3-monthly IAIs until exudative activity disappeared, 2) an observation phase, during which patients were monitored until exudative activity appeared, and 3) a TAE phase, for which the initial treatment interval was determined based on the disease recurrence interval, followed by treatment intervals changing by 2 weeks.\nRESULTS: Mean logMAR BCVA improved significantly from 0.48 ± 0.51 at baseline to 0.40 ± 0.53 at 12 months (P < 0.01), and was maintained (losing <0.3 logMAR units) in 35 eyes (97.2 %). Mean central retinal thickness and central choroidal thickness decreased significantly after 12 months. In the TAE phase, the distribution of treatment intervals was ≥8 weeks in 64.7 % (11 eyes) at 12 months. The mean number of injections was 4.53.\nCONCLUSION: A modified TAE regimen of IAI for neovascular AMD produced good functional outcomes over 12 months with the small number of injections."
},
{
"source_pmid": "28231566",
"source_text": "PURPOSE: We compared 1-year outcomes of 1 + pro re nata (PRN) versus 3 + PRN of intravitreal aflibercept injection (IAI) for age-related macular degeneration (AMD).\nMETHODS: Forty-two eyes with naïve AMD received 3 + PRN IAI treatment and 47 eyes with naïve AMD received 1 + PRN IAI treatment. Visual acuity (VA), central retinal thickness (CRT), and central choroidal thickness (CCT) and number of administered IAIs during 12 months were compared.\nRESULTS: VAs improved, and CRTs reduced significantly at any given month from baseline in both groups (p < 0.01, respectively). CCT reduced significantly at 3 months in the 3 + PRN group (p = 0.024) but not in the 1 + PRN group. The 1 + PRN group received fewer injections than the 3 + PRN group (p < 0.01).\nCONCLUSIONS: Aflibercept leads to equivalent VA and morphologic retinal improvement without administering 3 injections."
},
{
"source_pmid": "26578446",
"source_text": "PURPOSE: Aflibercept has the potential advantage of reducing capacity problems by allowing 2 monthly visits for patients with neovascular macular degeneration (nAMD) compared with monthly pro re nata regimens that are the most commonly used in the United Kingdom. This study aimed to report the visual outcomes achieved in routine clinical practice using the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) protocol at 1 year and compare with trials data and other real-world reports.\nDESIGN: Retrospective data analysis from an electronic medical record.\nPARTICIPANTS: Consecutive series of treatment-naïve patients initiated on aflibercept for nAMD at least 1 year before data extraction.\nMETHODS: Data were anonymized and remotely extracted from 16 centers in the United Kingdom that use the same electronic medical record (EMR) system (Medisoft Ophthalmology; Medisoft Limited, Leeds, UK).\nMAIN OUTCOME MEASURES: The minimum data set defined before first data entry and mandated by the EMR included age, gender, visual acuity, injection episodes, and complications.\nRESULTS: The mean age was 80.0 years (median, 81.0 years) and 63.7% were women. During the first year of treatment with aflibercept, 1840 treatment-naïve eyes of 1682 patients received a median of 8 (mean, 7.0) injections at a median of 8 (mean, 7.3) visits. The mean baseline visual acuity was 53.7 letters, improving to 58.8 letters (+5.1-letter gain) at 1 year. In first-treated eyes, the respective figures were 52.7 letters at baseline and 58.2 letters at 1 year, a gain of +5.5 letters. The proportion achieving 70 letters or more increased from 16.4% at baseline to 33.7% at 1 year, and 92% avoided moderate visual loss at 1 year.\nCONCLUSIONS: The visual acuity outcomes are comparable to randomized trials and better than many previous real-world data collections, with a mean +5.1-letter gain at 1 year compared with +8.4 letters in the integrated analysis of the VIEW 1 and VIEW 2 studies. Early visual gains were maintained through the year. Collection of outcomes beyond clinical trials can have limitations but better reflect the full pool of patients actually treated and are important to determine whether a particular treatment is performing as expected. Such data also have the potential to improve services by setting up a mechanism to compare sites."
},
{
"source_pmid": "27826933",
"source_text": "PURPOSE: To compare the responses of intravitreal injections of bevacizumab, ranibizumab, or aflibercept for the treatment of neovascular age-related macular degeneration (nAMD).\nMETHODS: This retrospective study examined 232 eyes of 232 patients who received intravitreal anti-vascular endothelial growth factor (VEGF) injections due to treatment-naïve nAMD. All patients, who were followed-up for at least 1 year, were treated with intravitreal injections monthly until 3 months, and then as needed. We evaluated the effects of intravitreal injections for treatment of nAMD using the central macular thickness (CMT), subretinal fluid (SRF), pigment epithelial detachment (PED) size, and best-corrected visual acuity (BCVA).\nRESULTS: CMT, SRF, PED size, and BCVA (LogMAR) were significantly decreased after treatment with all three anti-VEGF agents. Overall, the bevacizumab, ranibizumab, and aflibercept treatments showed no significant differences in their responses. However, the aflibercept injections decreased PED size more quickly than bevacizumab injections (P = 0.034).\nCONCLUSIONS: Bevacizumab, ranibizumab, and aflibercept injections are effective treatments for nAMD and have similar responses, although the number of injections of aflibercept was fewer than other anti-VEGF agents. In addition, aflibercept injections may be a better choice than other anti-VEGF agents for cases of severe increases in PED height."
},
{
"source_pmid": "27707549",
"source_text": "PURPOSE: To directly compare visual acuity (VA) outcomes with ranibizumab vs. aflibercept for eyes with neovascular age-related macular degeneration (nAMD) treated in routine clinical practice.\nDESIGN: Database observational study.\nPARTICIPANTS: Treatment-naïve eyes with nAMD tracked by the Fight Retinal Blindness outcome registry that commenced anti-vascular endothelial growth factor therapy with ranibizumab or aflibercept between December 1, 2013, and January 31, 2015. Eyes were matched at baseline for VA, age, and choroidal neovascular membrane (CNV) size.\nMETHODS: Locally weighted scatterplot smoothing curves were used to display VA results. Eyes that switched or discontinued treatment were included with their last observation carried forward.\nMAIN OUTCOME MEASURES: Change in mean VA (number of letters read on a logarithm of the minimum angle of resolution chart); number of injections and visits; proportion of eyes with inactive CNV over 12 months.\nRESULTS: We identified 394 eyes (197 treated with ranibizumab and 197 with aflibercept) from 372 patients who received treatment from 34 practitioners. Baseline parameters were well matched. The mean (standard deviation [SD]) VA of ranibizumab-treated eyes increased from 58.6 (20.3) letters at baseline to 62.3 (23.9) (+3.7 [95% confidence interval {CI} 1.4-6.1]) letters (P = 0.001), compared with 58.9 (19.2) letters at baseline to 63.1 (21.5) (+4.26 [95% CI 2.0-6.5]) letters (P < 0.001) for eyes receiving aflibercept. The difference in change in crude VA of 0.6 letters between the 2 groups was not statistically significant (P = 0.76), nor was the difference in adjusted mean VA of the 2 groups (P = 0.26). In completers, the mean (SD) numbers of injections (8.1 [2.1] vs. 8.0 [2.3]; P = 0.27) and visits (9.6 [3.0] vs. 9.5 [3.1]; P = 0.15) did not differ between the 2 groups. The adjusted proportion of eyes in which the CNV lesion was graded as inactive during the study was similar between the eyes receiving ranibizumab and aflibercept (74% vs. 77%, respectively; P = 0.63).\nCONCLUSIONS: Visual acuity outcomes at 12 months did not differ between ranibizumab and aflibercept used for nAMD in this large observational study, nor was a difference in treatment frequency found."
},
{
"source_pmid": "27746298",
"source_text": "PURPOSE: To report 2-year treatment outcomes with intravitreal aflibercept for neovascular age-related macular degeneration (nAMD) in routine clinical practice.\nDESIGN: Retrospective, nonrandomized, interventional case series.\nMETHODS: Retrospective analysis of electronic medical record (EMR) notes (OpenEyes) and paper case notes and review of spectral-domain optical coherence tomography (SDOCT) imaging of patients with consecutively treated eyes with previously untreated nAMD. Patients were commenced on aflibercept injections in 1 or both eyes from October 1, 2013 to December 31, 2013. Data including age, sex, visual acuity (VA) measured on Early Treatment Diabetic Retinopathy Study charts, injection episodes, and complications were recorded. Additionally, SDOCT data, including presence or absence of macular fluid and automated central subfield macular thickness (CSMT) at year 1 and 2, were recorded.\nRESULTS: Of the 109 eyes of 102 patients treated, data from 94 eyes of 88 patients were available at 2-year follow-up (86% of patients). In the analysis of 2-year outcomes, there were 58 women (65.9%); the mean (± standard deviation) age was 77.5 ± 8 years. Over the 2 years, these eyes received a median of 12 (mean, 11.4 ± 4) injections at a median of 100 (mean, 99.3 ± 5.3) weeks of follow-up. The mean VA changed from 55.9 ± 15 letters at baseline to 61.3 ± 16.9 letters (VA gain 5.4 letters) at 1 year and to 61 ± 17.1 letters (VA gain 5.1 ± 14.9 letters) at 2 years. The reduction in CSMT was 79 μm with absence of macular fluid in 72.7% of the 88 eyes with SDOCT data available at 2-year follow-up.\nCONCLUSIONS: The VA and SDOCT results compare favorably with outcomes seen in randomized controlled trials. The results suggest that good long-term outcomes can be achieved using aflibercept for nAMD in clinical settings."
},
{
"source_pmid": "27230919",
"source_text": "PURPOSE: To compare the 12-month treatment outcome of ranibizumab with that of aflibercept in cases of neovascular age-related macular degeneration (AMD).\nMETHODS: This retrospective single-institution study included patients who had been diagnosed with treatment-naïve neovascular AMD and treated using either ranibizumab (ranibizumab group, n = 30) or aflibercept (aflibercept group, n = 21) monotherapy over a 12-month follow-up period. Patients initially received three monthly injections, and were re-treated when neovascularization recurred. The best-corrected visual acuity (BCVA) at diagnosis and at 12 months, as well as the number of injections, were compared between the two groups.\nRESULTS: In the ranibizumab group, the mean logarithm of the minimum angle of resolution BCVA values at diagnosis and at 12 months were 0.86 ± 0.45 and 0.72 ± 0.56, respectively. The equivalent values were 0.73 ± 0.37 and 0.58 ± 0.41 in the aflibercept group. The mean number of injections was 4.5 ± 1.3 in the ranibizumab group and 4.3 ± 0.9 in the aflibercept group. There was no difference in BCVA between the two groups at either diagnosis (P = 0.560) or 12 months (P = 0.702). There was also no difference between the two groups in the number of injections (P = 0.847).\nCONCLUSION: The 12-month treatment outcome of intravitreal ranibizumab was similar to that of intravitreal aflibercept, with a comparable injection frequency. Further prospective studies with a more controlled design are needed to confirm our findings."
},
{
"source_pmid": "25634529",
"source_text": "PURPOSE: To investigate the efficacy of periodic injection of aflibercept in each subtype of age-related macular degeneration (AMD) and to explore the predictive factors for visual outcome in clinical settings.\nDESIGN: Prospective nonrandomized interventional case series.\nMETHODS: Patients with AMD were recruited and were administered aflibercept injections once a month for 3 months followed by once every 2 months for 8 months. The logarithm of the minimal angle of resolution (logMAR) at 12 months and improvement of vision from baseline were compared among polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), and typical AMD. Regression rate of polypoidal lesions was assessed. We also performed regression analysis with logMAR at 12 months as the dependent variable.\nRESULTS: The study sample consisted of 98 patients: 46 had typical AMD, 42 had PCV, and 10 had RAP. Mean logMAR improved from 0.36 to 0.21 in 12 months. While there was no difference in visual improvement between typical AMD and PCV, final logMAR was better in PCV (0.32 ± 0.09 vs 0.08 ± 0.04, P = .016). Thirty-nine PCV patients underwent follow-up angiography, and regression of polyps was observed in 27 cases (69.2%). Multiple regression analysis showed that the presence of external limiting membrane (ELM), smaller greatest linear dimension, and the presence of polypoidal lesion were associated with better visual outcome (R(2) = 0.53, P = 2.73 × 10(-14)).\nCONCLUSIONS: Periodic injection of aflibercept is effective for PCV as well as for typical AMD. The statuses of ELM, greatest linear dimension, and polypoidal lesion are predictive for visual outcome."
}
] |
26625212
|
AUTHORS' CONCLUSIONS: Overall, the use of devices with standard trabeculectomy may help with greater IOP reduction at one-year follow-up than trabeculectomy alone; however, due to potential biases and imprecision in effect estimates, the quality of evidence is low. When we examined outcomes within subgroups based on the type of device used, our findings suggested that the use of an Ex-PRESS device or an amniotic membrane as an adjunct to trabeculectomy may be slightly more effective in reducing IOP at one year after surgery compared with trabeculectomy alone. The evidence that these devices are as safe as trabeculectomy alone is unclear. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices and in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).
|
INTRODUCTION: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma.
METHODS: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and <or=18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and <or=15 mmHg was also noted.
RESULTS: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and <or=15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group.
CONCLUSIONS: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma. ||||| AIM: To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy.
METHODS: This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications.
RESULTS: The mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan-Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17 mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted.
CONCLUSIONS: Our results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate. ||||| PURPOSE: To compare outcomes of trabeculectomy combined with mitomycin C (MMC) and amniotic membrane transplantation (AMT) with those of trabeculectomy with MMC alone in refractory glaucoma.
METHODS: This prospective, randomized study included 37 eyes with refractory glaucoma at such high risks as neovascular, pseudophakic, and prior failure. Trabeculectomy with MMC and single-layer AMT under the scleral flap was performed in 19 eyes and trabeculectomy with MMC alone in 18 eyes. The outcome measures included intraocular pressure (IOP), number of antiglaucoma medications, and complications. All patients were followed for 12 months.
RESULTS: Complete success (IOP <22 mm Hg without glaucoma medications) was seen in 15/16 (93.7%) study eyes and 9/15 (60%) control eyes at 6 months postoperatively (P=0.03), and in 12/15 (80%) and 6/15 (40%) at 12 months after surgery, respectively (P=0.03). IOP decreased from 45.6+/-12.7 mm Hg and 44.9+/-10.7 mm Hg preoperatively in study and control groups to 15.3+/-2.3 mm Hg and 21.3+/-3.8 mm Hg, respectively, at 12 months (P<0.0001). Early postoperative hypotony developed in 3 (16.7%) control eyes owing to excessive filtration but none of study eyes (P=0.1). Encapsulated bleb occurred in 7 (38.9%) control eyes but in 1 (5.3%) study eye (P=0.02).
CONCLUSIONS: In refractory glaucoma, trabeculectomy combined with MMC and AMT compared to trabeculectomy with MMC alone has higher success rates, lower postoperative mean IOPs, and less complication rates. ||||| PURPOSE: To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy.
DESIGN: Randomized, prospective, multicenter trial.
METHODS: A total of 120 eyes in 120 subjects were analyzed, including 59 eyes treated with EX-PRESS and 61 eyes treated with trabeculectomy. Both the EX-PRESS and the trabeculectomy groups were treated intraoperatively with mitomycin C and followed postoperatively for 2 years. Surgical success was defined as 5 mm Hg ≤ intraocular pressure ≤ 18 mm Hg, with or without medications, without further glaucoma surgery.
RESULTS: Mean intraocular pressure was significantly reduced compared with baseline in both groups (P < 0.001). Average intraocular pressure and number of medications were similar in both groups during follow-up, with mean intraocular pressure at 2 years after surgery of 14.7 ± 4.6 mm Hg and 14.6 ± 7.1 mm Hg in the EX-PRESS and trabeculectomy groups, respectively (P = 0.927). At 2 years after surgery, the success rate was 83% and 79% in the EX-PRESS and trabeculectomy groups, respectively (P = 0.563). Although visual acuity (logMAR) was significantly decreased on day 1 in both groups, the vision was not significantly different compared with baseline at 1 month after EX-PRESS implant (P = 0.285) and 3 months after trabeculectomy (P = 0.255). The variance of early postoperative intraocular pressure values was similar between groups on the first postoperative day but higher after trabeculectomy compared with EX-PRESS implant on day 7 (P = 0.003). The total number of postoperative complications was higher after trabeculectomy than after EX-PRESS implantation (P = 0.013).
CONCLUSIONS: Mean intraocular pressures, medication use, and surgical success were similar at 2 years after treatment with the EX-PRESS device and trabeculectomy. Vision recovery between groups was also similar throughout the study, although return to baseline vision was more rapid in the EX-PRESS group. Intraocular pressure variation was lower during the early postoperative period, and postoperative complications were less common after EX-PRESS implantation compared with trabeculectomy. ||||| PURPOSE: To present the preliminary results of our study comparing the outcomes of trabeculectomy with or without OloGen implant in patients requiring glaucoma surgery for uncontrolled intraocular pressure (IOP).
METHODS: Forty eyes of 40 patients were assigned randomly to undergo trabeculectomy either with OloGen implant (study group) or without implant (control group). Preoperative data included age, gender, type of glaucoma, IOP and number of preoperative glaucoma medications. Postoperative IOP, number of postoperative glaucoma medications and postoperative complications were recorded. Each patient was followed up for at least 6 months.
RESULTS: There were no significant differences between the groups in terms of age, gender, type of glaucoma, preoperative IOP and number of antiglaucoma medications. Mean IOPs for both groups were significantly lower than preoperative levels at all intervals (P < 0.05) The number of glaucoma medications used dropped from a preoperative mean of 3.5 +/- 0.7 to a 6-month postoperative mean of 0.3 +/- 0.7 (P < 0.001) in the study group and from 3.7 +/- 0.4 to 0.5 +/- 1.1 (P < 0.001) in the control group. No statistically significant differences between the two groups were observed in terms of postoperative complications.
CONCLUSION: In this pilot study it appears that trabeculectomy with OloGen does not seem to offer any significant advantages compared with trabeculectomy alone. Additionally, even though there were no statistical differences between the two groups as far as complications were concerned, one eye from the study group developed endophthalmitis 10 days after surgery and two eyes presented with positive Seidel test and flat anterior chamber and required additional suturing. Studies with larger numbers of patients and longer follow-ups are required to confirm these findings and to examine the safety and long-term outcomes of trabeculectomy with OloGen. ||||| BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.
METHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.
RESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.
CONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma. ||||| PURPOSE: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC).
MATERIALS AND METHODS: In a prospective, randomized, pilot study, 39 eyes of 33 subjects with medically uncontrolled primary glaucoma, aged 18 years or above underwent trabeculectomy either with MMC (20 eyes) or with Ologen implant (19 eyes). The primary outcome measure was cumulative success probability, defined as complete if the intraocular pressure (IOP) was > 5 and ≤ 21 mm Hg without anti-glaucoma medications or additional surgery and qualified if an IOP was > 5 and ≤ 21 mm Hg with or without anti-glaucoma medications.
RESULTS: Mean (± standard deviation) follow-up in Ologen group was 19.1 ± 8.1 months, and in MMC group was 18.0 ± 8.4 months. Mean IOP reduction at 6 months was significantly lower (P = 0.01) in the MMC group (11.9 ± 2.9 mm Hg) as compared to Ologen group (14.6 ± 2.7 mm Hg). However, at 12 months (P = 0.81) and 24 months (P = 0.32), the mean IOP was similar between the 2 groups. Complete success probability at the end of 6 months in Ologen group was 100% (95% confidence interval: 59.1 - 99.0) was similar (P = 0.53) to that in MMC group (93.8%, 95% CI: 63.2 - 99.1). The incidences of early post-operative complications were similar in the 2 groups, except hyphema, which was significantly more in Ologen group (P = 0.02).
CONCLUSION: In this pilot study, the success of trabeculectomy and complications were similar in both Ologen and MMC groups at the end of 6 months. ||||| PURPOSE: To compare the safety and efficacy of human preserved amniotic membrane (AM) in the trabeculectomy for treatment of primary open-angle glaucoma.
METHODS: A prospective, randomized clinical trial compared primary trabeculectomy with amniotic membrane (study group) and without amniotic membrane (control group) in the treatment of the glaucoma. Intraocular pressure (IOP), number of glaucoma medications and appearance of the bleb were compared between the two groups. Thirty-two patients divided into two groups of 16 patients were followed for a period of 12 months.
RESULTS: The difference of the mean postoperative intraocular pressure between groups was not statistically significant (15.19 +/- 3.33 in the control group and 12.81 +/- 2.48 in the study group p=0.297) at one year follow-up. Postoperative number of medications decreased in both groups (p<0.001 and p=0.007, study group and control respectively). At the end of a 12-month follow-up period, nine eyes (56.25%) showed thin, avascular blebs in the study group as compared to only one eye (6.25%) in the control group.
CONCLUSIONS: Trabeculectomy with amniotic membrane and standard trabeculectomy promote lower postoperative intraocular pressure although results showed no statistically significant difference between groups regarding postoperative intraocular pressure after one year follow-up. ||||| PURPOSE: To compare the rate of visual recovery after Ex-PRESS implantation versus standard trabeculectomy.
PATIENTS AND METHODS: Subjects enrolled in a prospective randomized controlled trial comparing Ex-PRESS to trabeculectomy were analyzed for postoperative changes in visual acuity (VA). Risk factors for visual loss (split fixation, cup-disc ratio, intraocular pressure, visual field mean deviation, and hypotony) were evaluated.
RESULTS: Sixty-four subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). There was no significant difference in mean logMAR VA between groups at baseline or any study visit. VA was significantly reduced up to week 2 following surgery in both the groups. However, by month 1, VA in the Ex-PRESS group was no longer significantly different from baseline (P=0.23) and remained nonsignificant at subsequent visits up to 6 months. In the trabeculectomy group, VA remained significantly lower than baseline at each study visit. At 6 months, 47% of the trabeculectomy eyes compared with 16% of the Ex-PRESS eyes had lost ≥2 Snellen lines (P=0.01). Reasons for VA loss included cataract, central retinal vein occlusion, and diabetic retinopathy, however, in a significant number of cases no cause could be determined. None of the risk factors evaluated were associated with vision loss.
CONCLUSIONS: Although there was no difference in mean VA between the Ex-PRESS and trabeculectomy groups at any time point, trabeculectomy eyes were more likely to lose ≥2 Snellen lines. In addition, VA recovered faster in the Ex-PRESS group. ||||| PURPOSE: To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial.
METHODS: In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied.
RESULTS: Mean preoperative intraocular pressure (IOP) levels (OLO: 28.0 ± 9.4; MMC: 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO: 3.4 ± 1.6; MMC: 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01).
CONCLUSIONS: With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group. ||||| PURPOSE: The aim of this study is to assess the efficacy and complications of trabeculectomy with a biodegradable implant (ologen implant) vs trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open-angle glaucoma in a prospective randomised clinical trial.
METHODS: In the MMC group (10 patients), trabeculectomy was performed according to standard protocols. In the ologen group (10 patients) after standard trabeculectomy the implant was positioned on top of the scleral flap and no MMC was applied. Follow-up was continued for 12 months after surgery and included testing of intraocular pressure (IOP), visual acuity, visual field, ultrasound biomicroscopy, and filtering bleb score.
RESULTS: The mean preoperative IOP was 24.8+/-8.9 mm Hg for all patients enrolled. At 1 year after surgery, the mean IOP was 15.6+/-2.4mm Hg in the ologen group (P<0.01, 43% reduction) and 11.5+/-4.1 mm Hg in the MMC group (P<0.01, 50% reduction). No anti-glaucomatous medication was necessary in the MMC group in the first year of follow-up, whereas five patients in the ologen group required topical treatment. The absolute success rate was 100% in the MMC group and 50% in the ologen group (P=0.01). After 1 year, filtering blebs developed significantly more avascular areas in the MMC group (score=1.4) than in the ologen group (score=2.8; P<0.01).
CONCLUSION: The complete success rate using trabeculectomy with the ologen implant is lower than that achieved by trabeculectomy with MMC. However, the bleb morphology caused more problems in the MMC group (avascularity score). ||||| PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).
DESIGN: Prospective, randomised study.
PATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.
RESULTS: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.
CONCLUSIONS: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications. ||||| PURPOSE: To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy.
PATIENTS AND METHODS: Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%.
RESULTS: Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups.
CONCLUSIONS: There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology. ||||| BACKGROUND: To investigate the effectiveness of amniotic membrane transplantation (AMT) on improving the outcomes of trabeculectomy in primary open-angle glaucoma (POAG).
METHODS: Fifty-nine eyes affected by primary open-angle glaucoma were enrolled in this prospective randomized study. Thirty-two eyes underwent amnion-shielded trabeculectomy (study group) and 27 eyes underwent trabeculectomy without any antimetabolites (control group). Success was defined as intraocular pressure (IOP) <21 mmHg without any medications at 24 months follow-up. The two groups were compared in terms of IOP, bleb morphology, bleb survival and risk of failure, glaucoma medications, and complications.
RESULTS: There was no statistically significant difference in terms of postoperative IOP between the two groups and at 24 months median IOP was 15.5 mmHg for the AMT group and 16 mmHg for the control group. IOP postoperative reduction was 8 mmHg for the AMT group versus 6 mmHg for the non AMT group (P = 0.276). Two patients from the study group developed IOP >21 mmHg in contrast to seven patients from the classic trabeculectomy group. The study group had 61.0% less risk of developing IOP >21 mmHg (P = 0.203). No major complications in the AMT group were observed. AMT blebs were diffuse with mild vascularization.
CONCLUSION: In patients with POAG, AMT showed favorable effects on bleb survival, however data failed to provide firm evidence that AMT could be used as a routine procedure in trabeculectomy. ||||| PURPOSE: To evaluate the intraocular pressure (IOP)-lowering effect of trabeculectomy with the use of amniotic membrane transplant (AMT) compared with the standard trabeculectomy with Mitomycin-C (MMC) in patients with primary open-angle glaucoma.
PATIENTS AND METHODS: This study was a patient-masked, randomized, controlled comparison trial involving 52 eyes of 52 patients with bilateral primary open-angle glaucoma. Patients were randomized to receive trabeculectomy with AMT or trabeculectomy with MMC. The main outcome for comparison was the IOP-lowering effect of both procedures. Surgical success was considered if the patient's IOP was <22 mm Hg, and the IOPs were lowered by >20% without the use of any medication.
RESULTS: All surgeries passed uneventfully without intraoperative complications, and all patients showed significantly (P<0.05) lower IOP on the first postoperative day compared with their respective preoperative IOP with nonsignificant (P>0.05) difference between both study groups. All patients, irrespective of the operative procedure maintained significantly (P<0.05) lower IOP compared with their respective preoperative IOP till the end of 24 months follow-up. Moreover, patients of the AMT group showed lower IOP compared with those included in the MMC group throughout the follow-up period; however, the difference was not statistically significant at any point of the study period.
CONCLUSIONS: AMT exhibits potential as an alternative to MMC in trabeculectomy surgery. Over 24 months of follow-up, the use of AMT with trabeculectomy was safe and effective with an IOP-lowering effect comparable to that achieved with the use of MMC, and a reduced rate of postoperative complication. ||||| PURPOSE: Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy. This study aimed to compare the 1-year cost differences between the 2 operations.
METHODS: Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy. Surgical cost difference and 1-year postoperative costs (follow-up visits, additional procedures, and medications) were determined and compared. The 95% confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method.
RESULTS: Forty-three subjects with 1-year follow-up were included. Success rate was not significantly different for Ex-PRESS (65%) versus trabeculectomy (55%, P=0.49). Ex-PRESS had a net surgical cost of $956 greater than trabeculectomy. There was no significant difference in the overall postoperative cost [median (interquartile range); $485 (337, 822) vs. $609 (387, 820), P=0.78], cost of follow-up visits [$303 (275, 358) vs. $317 (275, 385), P=0.75], additional procedures [$182 (0, 365) vs. $182 (0, 365), P=0.69], or glaucoma medication [$0 (0, 68) vs. $0 (0, 90), P=0.8] for Ex-PRESS versus trabeculectomy, respectively. The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $9625 (95% confidence interval, $2435-548,084).
CONCLUSIONS: Ex-PRESS is associated with greater surgical cost compared with trabeculectomy. This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy. ||||| AIM: To observe effects of trabeculectomy with amniotic membrane transplantation (AMT) in controlling postoperative intraocular pressure (IOP) in patients with medically uncontrolled glaucoma.
METHODS: This study included adult patients with requiring bilateral glaucoma surgery. Each patient underwent trabeculectomy (Non-AMT group) in one eye and with AMT (AMT group) in the other eye according to randomized principle. Success was defined as intraocular pressure (IOP)<21mmHg without any anti-glaucoma medications at 24 months follow-up. The two groups were compared in terms of IOP, complications and success rate.
RESULTS: Thirty-four eyes of 17 patients were investigated in this study. There was no statistically signifcant difference in pre-operative IOP between the two groups. The mean IOP was lower in AMT group compared with Non-AMT group on follow up months 12, 18, and 24.Postoperative complications were more frequent in Non-AMT group (35.3%, 6/17) compared with AMT group (5.9%, 1/17). The success rate of surgery was 88.2% (15/17) in Non-AMT group and 100% (17/17) in AMT group.
CONCLUSION: Trabeculectomy with AMT is an effective procedure to reduce IOP and complications, thereby improving surgical success rates. ||||| PURPOSE: To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy.
METHODS: Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels -< or =21 and < or =17 mmHg - by Kaplan-Meier curves.
RESULTS: The postoperative IOP reduction was significant (P < 0.01) at the endpoint in all groups, with a mean IOP of 16.9 (+/-2.9), 16.2 (+/-2.7), 15.3 (+/-3.4) and 15.2 (+/-4.3) mmHg in T, TMMC, TG and TGMMC eyes, respectively. No intergroup difference was found at either IOP targets. The Kaplan-Meier curves relating to either the < or =21 mmHg or the < or =17 mmHg target IOP did not show significant intergroup differences for complete and qualified success rate. When ePTFE was used, a trend favouring the medium-term survival rate was noted. No adverse reaction to the ePTFE was present, and no membrane extrusion or conjuctival erosion were noted in any cases. Hypotony was significantly more frequent (P = 0.035) in groups without ePTFE. Moreover, the late MMC-related complications were more frequent when MMC was applied.
CONCLUSION: Expanded polytetrafluoroethylene implant in trabeculectomy is well tolerated and could act as a filtration modulating device. Therefore, it is useful in reducing early hypotony-related complications and contributes to attaining medium-term IOP control that is comparable to the low-dosage MMC. ||||| PURPOSE: To compare the results of subscleral trabeculectomy (SST) augmented with mitomycin-C (MMC) versus Ologen™ implant regarding intraocular pressure (IOP) control and incidence of complications.
METHODS: Sixty eyes of 60 patients, who planned to undergo SST, were divided into 2 groups. Group I eyes (included thirty eyes) were operated upon with SST augmented with intraoperative MMC. Group II eyes (included 30 eyes) were operated upon with SST using an Ologen implant. IOP and bleb status, as well as reporting postoperative complications, were followed up.
RESULTS: The follow-up period was 12 months. At 12 months postoperatively, the mean IOP was 19.33±3.22 mmHg in group I, and 19.87±4.17 mmHg in group II, with no significant difference between groups. One case in each group had hyphema, and 4 cases in group I and 2 cases in group II had shallow anterior chamber. One case in group I and no cases in group II had blebitis. There was no significant difference regarding the complications between both groups.
CONCLUSION: We conclude that the use of the Ologen implant in SST is comparable to the use of MMC with advantage of avoiding the potential dangerous complications related to MMC use in the early (12 months) follow-up period.
|
[
{
"source_pmid": "19337705",
"source_text": "INTRODUCTION: The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma.\nMETHODS: This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a scleral flap, or trabeculectomy. The main outcome measures were: mean intraocular pressure (IOP), postoperative medication use, visual acuity, and incidence of complications. Complete success was defined as an IOP of >4 mmHg and <or=18 mmHg without the use of antiglaucoma medications. A more stringent target of IOP >4 mmHg and <or=15 mmHg was also noted.\nRESULTS: There were 78 patients (80 eyes) with primary open-angle, pseudoexfoliative, or pigmentary glaucoma enrolled in the study. A total of 84.6% of patients receiving Ex-PRESS and 60.0% of patients receiving trabeculectomy (P=0.0230) achieved complete success. The respective proportions of patients achieving an IOP >4 mmHg and <or=15 mmHg were 76.9% and 50.0% (P=0.0193). At 1-year follow-up, complete success rates were 81.8% for Ex-PRESS and 47.5% for trabeculectomy (P=0.0020), and 71.7% and 37.5% (P=0.0070), respectively, for the more stringent target. There was a similar level of postoperative interventions and complications for each group.\nCONCLUSIONS: In open-angle glaucoma, the Ex-PRESS mini glaucoma shunt implanted under a superficial scleral flap produces significantly higher success rates, and a similar complication rate, compared with trabeculectomy. The Ex-PRESS is a safe and effective device for treating open-angle glaucoma."
},
{
"source_pmid": "21921953",
"source_text": "AIM: To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy.\nMETHODS: This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications.\nRESULTS: The mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan-Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17 mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted.\nCONCLUSIONS: Our results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate."
},
{
"source_pmid": "18552616",
"source_text": "PURPOSE: To compare outcomes of trabeculectomy combined with mitomycin C (MMC) and amniotic membrane transplantation (AMT) with those of trabeculectomy with MMC alone in refractory glaucoma.\nMETHODS: This prospective, randomized study included 37 eyes with refractory glaucoma at such high risks as neovascular, pseudophakic, and prior failure. Trabeculectomy with MMC and single-layer AMT under the scleral flap was performed in 19 eyes and trabeculectomy with MMC alone in 18 eyes. The outcome measures included intraocular pressure (IOP), number of antiglaucoma medications, and complications. All patients were followed for 12 months.\nRESULTS: Complete success (IOP <22 mm Hg without glaucoma medications) was seen in 15/16 (93.7%) study eyes and 9/15 (60%) control eyes at 6 months postoperatively (P=0.03), and in 12/15 (80%) and 6/15 (40%) at 12 months after surgery, respectively (P=0.03). IOP decreased from 45.6+/-12.7 mm Hg and 44.9+/-10.7 mm Hg preoperatively in study and control groups to 15.3+/-2.3 mm Hg and 21.3+/-3.8 mm Hg, respectively, at 12 months (P<0.0001). Early postoperative hypotony developed in 3 (16.7%) control eyes owing to excessive filtration but none of study eyes (P=0.1). Encapsulated bleb occurred in 7 (38.9%) control eyes but in 1 (5.3%) study eye (P=0.02).\nCONCLUSIONS: In refractory glaucoma, trabeculectomy combined with MMC and AMT compared to trabeculectomy with MMC alone has higher success rates, lower postoperative mean IOPs, and less complication rates."
},
{
"source_pmid": "24210765",
"source_text": "PURPOSE: To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy.\nDESIGN: Randomized, prospective, multicenter trial.\nMETHODS: A total of 120 eyes in 120 subjects were analyzed, including 59 eyes treated with EX-PRESS and 61 eyes treated with trabeculectomy. Both the EX-PRESS and the trabeculectomy groups were treated intraoperatively with mitomycin C and followed postoperatively for 2 years. Surgical success was defined as 5 mm Hg ≤ intraocular pressure ≤ 18 mm Hg, with or without medications, without further glaucoma surgery.\nRESULTS: Mean intraocular pressure was significantly reduced compared with baseline in both groups (P < 0.001). Average intraocular pressure and number of medications were similar in both groups during follow-up, with mean intraocular pressure at 2 years after surgery of 14.7 ± 4.6 mm Hg and 14.6 ± 7.1 mm Hg in the EX-PRESS and trabeculectomy groups, respectively (P = 0.927). At 2 years after surgery, the success rate was 83% and 79% in the EX-PRESS and trabeculectomy groups, respectively (P = 0.563). Although visual acuity (logMAR) was significantly decreased on day 1 in both groups, the vision was not significantly different compared with baseline at 1 month after EX-PRESS implant (P = 0.285) and 3 months after trabeculectomy (P = 0.255). The variance of early postoperative intraocular pressure values was similar between groups on the first postoperative day but higher after trabeculectomy compared with EX-PRESS implant on day 7 (P = 0.003). The total number of postoperative complications was higher after trabeculectomy than after EX-PRESS implantation (P = 0.013).\nCONCLUSIONS: Mean intraocular pressures, medication use, and surgical success were similar at 2 years after treatment with the EX-PRESS device and trabeculectomy. Vision recovery between groups was also similar throughout the study, although return to baseline vision was more rapid in the EX-PRESS group. Intraocular pressure variation was lower during the early postoperative period, and postoperative complications were less common after EX-PRESS implantation compared with trabeculectomy."
},
{
"source_pmid": "19900209",
"source_text": "PURPOSE: To present the preliminary results of our study comparing the outcomes of trabeculectomy with or without OloGen implant in patients requiring glaucoma surgery for uncontrolled intraocular pressure (IOP).\nMETHODS: Forty eyes of 40 patients were assigned randomly to undergo trabeculectomy either with OloGen implant (study group) or without implant (control group). Preoperative data included age, gender, type of glaucoma, IOP and number of preoperative glaucoma medications. Postoperative IOP, number of postoperative glaucoma medications and postoperative complications were recorded. Each patient was followed up for at least 6 months.\nRESULTS: There were no significant differences between the groups in terms of age, gender, type of glaucoma, preoperative IOP and number of antiglaucoma medications. Mean IOPs for both groups were significantly lower than preoperative levels at all intervals (P < 0.05) The number of glaucoma medications used dropped from a preoperative mean of 3.5 +/- 0.7 to a 6-month postoperative mean of 0.3 +/- 0.7 (P < 0.001) in the study group and from 3.7 +/- 0.4 to 0.5 +/- 1.1 (P < 0.001) in the control group. No statistically significant differences between the two groups were observed in terms of postoperative complications.\nCONCLUSION: In this pilot study it appears that trabeculectomy with OloGen does not seem to offer any significant advantages compared with trabeculectomy alone. Additionally, even though there were no statistical differences between the two groups as far as complications were concerned, one eye from the study group developed endophthalmitis 10 days after surgery and two eyes presented with positive Seidel test and flat anterior chamber and required additional suturing. Studies with larger numbers of patients and longer follow-ups are required to confirm these findings and to examine the safety and long-term outcomes of trabeculectomy with OloGen."
},
{
"source_pmid": "21607021",
"source_text": "BACKGROUND: This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.\nMETHODS: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.\nRESULTS: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.\nCONCLUSION: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma."
},
{
"source_pmid": "23571259",
"source_text": "PURPOSE: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC).\nMATERIALS AND METHODS: In a prospective, randomized, pilot study, 39 eyes of 33 subjects with medically uncontrolled primary glaucoma, aged 18 years or above underwent trabeculectomy either with MMC (20 eyes) or with Ologen implant (19 eyes). The primary outcome measure was cumulative success probability, defined as complete if the intraocular pressure (IOP) was > 5 and ≤ 21 mm Hg without anti-glaucoma medications or additional surgery and qualified if an IOP was > 5 and ≤ 21 mm Hg with or without anti-glaucoma medications.\nRESULTS: Mean (± standard deviation) follow-up in Ologen group was 19.1 ± 8.1 months, and in MMC group was 18.0 ± 8.4 months. Mean IOP reduction at 6 months was significantly lower (P = 0.01) in the MMC group (11.9 ± 2.9 mm Hg) as compared to Ologen group (14.6 ± 2.7 mm Hg). However, at 12 months (P = 0.81) and 24 months (P = 0.32), the mean IOP was similar between the 2 groups. Complete success probability at the end of 6 months in Ologen group was 100% (95% confidence interval: 59.1 - 99.0) was similar (P = 0.53) to that in MMC group (93.8%, 95% CI: 63.2 - 99.1). The incidences of early post-operative complications were similar in the 2 groups, except hyphema, which was significantly more in Ologen group (P = 0.02).\nCONCLUSION: In this pilot study, the success of trabeculectomy and complications were similar in both Ologen and MMC groups at the end of 6 months."
},
{
"source_pmid": "16936950",
"source_text": "PURPOSE: To compare the safety and efficacy of human preserved amniotic membrane (AM) in the trabeculectomy for treatment of primary open-angle glaucoma.\nMETHODS: A prospective, randomized clinical trial compared primary trabeculectomy with amniotic membrane (study group) and without amniotic membrane (control group) in the treatment of the glaucoma. Intraocular pressure (IOP), number of glaucoma medications and appearance of the bleb were compared between the two groups. Thirty-two patients divided into two groups of 16 patients were followed for a period of 12 months.\nRESULTS: The difference of the mean postoperative intraocular pressure between groups was not statistically significant (15.19 +/- 3.33 in the control group and 12.81 +/- 2.48 in the study group p=0.297) at one year follow-up. Postoperative number of medications decreased in both groups (p<0.001 and p=0.007, study group and control respectively). At the end of a 12-month follow-up period, nine eyes (56.25%) showed thin, avascular blebs in the study group as compared to only one eye (6.25%) in the control group.\nCONCLUSIONS: Trabeculectomy with amniotic membrane and standard trabeculectomy promote lower postoperative intraocular pressure although results showed no statistically significant difference between groups regarding postoperative intraocular pressure after one year follow-up."
},
{
"source_pmid": "23807352",
"source_text": "PURPOSE: To compare the rate of visual recovery after Ex-PRESS implantation versus standard trabeculectomy.\nPATIENTS AND METHODS: Subjects enrolled in a prospective randomized controlled trial comparing Ex-PRESS to trabeculectomy were analyzed for postoperative changes in visual acuity (VA). Risk factors for visual loss (split fixation, cup-disc ratio, intraocular pressure, visual field mean deviation, and hypotony) were evaluated.\nRESULTS: Sixty-four subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). There was no significant difference in mean logMAR VA between groups at baseline or any study visit. VA was significantly reduced up to week 2 following surgery in both the groups. However, by month 1, VA in the Ex-PRESS group was no longer significantly different from baseline (P=0.23) and remained nonsignificant at subsequent visits up to 6 months. In the trabeculectomy group, VA remained significantly lower than baseline at each study visit. At 6 months, 47% of the trabeculectomy eyes compared with 16% of the Ex-PRESS eyes had lost ≥2 Snellen lines (P=0.01). Reasons for VA loss included cataract, central retinal vein occlusion, and diabetic retinopathy, however, in a significant number of cases no cause could be determined. None of the risk factors evaluated were associated with vision loss.\nCONCLUSIONS: Although there was no difference in mean VA between the Ex-PRESS and trabeculectomy groups at any time point, trabeculectomy eyes were more likely to lose ≥2 Snellen lines. In addition, VA recovered faster in the Ex-PRESS group."
},
{
"source_pmid": "24401481",
"source_text": "PURPOSE: To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial.\nMETHODS: In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied.\nRESULTS: Mean preoperative intraocular pressure (IOP) levels (OLO: 28.0 ± 9.4; MMC: 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO: 3.4 ± 1.6; MMC: 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01).\nCONCLUSIONS: With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group."
},
{
"source_pmid": "20733558",
"source_text": "PURPOSE: The aim of this study is to assess the efficacy and complications of trabeculectomy with a biodegradable implant (ologen implant) vs trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open-angle glaucoma in a prospective randomised clinical trial.\nMETHODS: In the MMC group (10 patients), trabeculectomy was performed according to standard protocols. In the ologen group (10 patients) after standard trabeculectomy the implant was positioned on top of the scleral flap and no MMC was applied. Follow-up was continued for 12 months after surgery and included testing of intraocular pressure (IOP), visual acuity, visual field, ultrasound biomicroscopy, and filtering bleb score.\nRESULTS: The mean preoperative IOP was 24.8+/-8.9 mm Hg for all patients enrolled. At 1 year after surgery, the mean IOP was 15.6+/-2.4mm Hg in the ologen group (P<0.01, 43% reduction) and 11.5+/-4.1 mm Hg in the MMC group (P<0.01, 50% reduction). No anti-glaucomatous medication was necessary in the MMC group in the first year of follow-up, whereas five patients in the ologen group required topical treatment. The absolute success rate was 100% in the MMC group and 50% in the ologen group (P=0.01). After 1 year, filtering blebs developed significantly more avascular areas in the MMC group (score=1.4) than in the ologen group (score=2.8; P<0.01).\nCONCLUSION: The complete success rate using trabeculectomy with the ologen implant is lower than that achieved by trabeculectomy with MMC. However, the bleb morphology caused more problems in the MMC group (avascularity score)."
},
{
"source_pmid": "22344189",
"source_text": "PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).\nDESIGN: Prospective, randomised study.\nPATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.\nRESULTS: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.\nCONCLUSIONS: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications."
},
{
"source_pmid": "24247999",
"source_text": "PURPOSE: To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy.\nPATIENTS AND METHODS: Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%.\nRESULTS: Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups.\nCONCLUSIONS: There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology."
},
{
"source_pmid": "22347791",
"source_text": "BACKGROUND: To investigate the effectiveness of amniotic membrane transplantation (AMT) on improving the outcomes of trabeculectomy in primary open-angle glaucoma (POAG).\nMETHODS: Fifty-nine eyes affected by primary open-angle glaucoma were enrolled in this prospective randomized study. Thirty-two eyes underwent amnion-shielded trabeculectomy (study group) and 27 eyes underwent trabeculectomy without any antimetabolites (control group). Success was defined as intraocular pressure (IOP) <21 mmHg without any medications at 24 months follow-up. The two groups were compared in terms of IOP, bleb morphology, bleb survival and risk of failure, glaucoma medications, and complications.\nRESULTS: There was no statistically significant difference in terms of postoperative IOP between the two groups and at 24 months median IOP was 15.5 mmHg for the AMT group and 16 mmHg for the control group. IOP postoperative reduction was 8 mmHg for the AMT group versus 6 mmHg for the non AMT group (P = 0.276). Two patients from the study group developed IOP >21 mmHg in contrast to seven patients from the classic trabeculectomy group. The study group had 61.0% less risk of developing IOP >21 mmHg (P = 0.203). No major complications in the AMT group were observed. AMT blebs were diffuse with mild vascularization.\nCONCLUSION: In patients with POAG, AMT showed favorable effects on bleb survival, however data failed to provide firm evidence that AMT could be used as a routine procedure in trabeculectomy."
},
{
"source_pmid": "24844538",
"source_text": "PURPOSE: To evaluate the intraocular pressure (IOP)-lowering effect of trabeculectomy with the use of amniotic membrane transplant (AMT) compared with the standard trabeculectomy with Mitomycin-C (MMC) in patients with primary open-angle glaucoma.\nPATIENTS AND METHODS: This study was a patient-masked, randomized, controlled comparison trial involving 52 eyes of 52 patients with bilateral primary open-angle glaucoma. Patients were randomized to receive trabeculectomy with AMT or trabeculectomy with MMC. The main outcome for comparison was the IOP-lowering effect of both procedures. Surgical success was considered if the patient's IOP was <22 mm Hg, and the IOPs were lowered by >20% without the use of any medication.\nRESULTS: All surgeries passed uneventfully without intraoperative complications, and all patients showed significantly (P<0.05) lower IOP on the first postoperative day compared with their respective preoperative IOP with nonsignificant (P>0.05) difference between both study groups. All patients, irrespective of the operative procedure maintained significantly (P<0.05) lower IOP compared with their respective preoperative IOP till the end of 24 months follow-up. Moreover, patients of the AMT group showed lower IOP compared with those included in the MMC group throughout the follow-up period; however, the difference was not statistically significant at any point of the study period.\nCONCLUSIONS: AMT exhibits potential as an alternative to MMC in trabeculectomy surgery. Over 24 months of follow-up, the use of AMT with trabeculectomy was safe and effective with an IOP-lowering effect comparable to that achieved with the use of MMC, and a reduced rate of postoperative complication."
},
{
"source_pmid": "25079306",
"source_text": "PURPOSE: Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy. This study aimed to compare the 1-year cost differences between the 2 operations.\nMETHODS: Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy. Surgical cost difference and 1-year postoperative costs (follow-up visits, additional procedures, and medications) were determined and compared. The 95% confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method.\nRESULTS: Forty-three subjects with 1-year follow-up were included. Success rate was not significantly different for Ex-PRESS (65%) versus trabeculectomy (55%, P=0.49). Ex-PRESS had a net surgical cost of $956 greater than trabeculectomy. There was no significant difference in the overall postoperative cost [median (interquartile range); $485 (337, 822) vs. $609 (387, 820), P=0.78], cost of follow-up visits [$303 (275, 358) vs. $317 (275, 385), P=0.75], additional procedures [$182 (0, 365) vs. $182 (0, 365), P=0.69], or glaucoma medication [$0 (0, 68) vs. $0 (0, 90), P=0.8] for Ex-PRESS versus trabeculectomy, respectively. The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $9625 (95% confidence interval, $2435-548,084).\nCONCLUSIONS: Ex-PRESS is associated with greater surgical cost compared with trabeculectomy. This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy."
},
{
"source_pmid": "23991376",
"source_text": "AIM: To observe effects of trabeculectomy with amniotic membrane transplantation (AMT) in controlling postoperative intraocular pressure (IOP) in patients with medically uncontrolled glaucoma.\nMETHODS: This study included adult patients with requiring bilateral glaucoma surgery. Each patient underwent trabeculectomy (Non-AMT group) in one eye and with AMT (AMT group) in the other eye according to randomized principle. Success was defined as intraocular pressure (IOP)<21mmHg without any anti-glaucoma medications at 24 months follow-up. The two groups were compared in terms of IOP, complications and success rate.\nRESULTS: Thirty-four eyes of 17 patients were investigated in this study. There was no statistically signifcant difference in pre-operative IOP between the two groups. The mean IOP was lower in AMT group compared with Non-AMT group on follow up months 12, 18, and 24.Postoperative complications were more frequent in Non-AMT group (35.3%, 6/17) compared with AMT group (5.9%, 1/17). The success rate of surgery was 88.2% (15/17) in Non-AMT group and 100% (17/17) in AMT group.\nCONCLUSION: Trabeculectomy with AMT is an effective procedure to reduce IOP and complications, thereby improving surgical success rates."
},
{
"source_pmid": "17995980",
"source_text": "PURPOSE: To test the expanded polytetrafluoroethylene (ePTFE) as a new adjuvant in trabeculectomy.\nMETHODS: Consecutive glaucoma surgical inpatients were observed at the Department of Ophthalmology of Palermo University. Sixty patients (60 eyes) were randomly assigned to undergo trabeculectomy (T), trabeculectomy with mitomycin-C (TMMC), with ePTFE (TG) or with mitomycin-C and ePTFE (TGMMC). Postoperative visits were scheduled at 24 hr, 7 days, 1, 3, 6, 12, 18 and 24 months. Complete success and qualified success were assessed at two target intraocular pressure (IOP) levels -< or =21 and < or =17 mmHg - by Kaplan-Meier curves.\nRESULTS: The postoperative IOP reduction was significant (P < 0.01) at the endpoint in all groups, with a mean IOP of 16.9 (+/-2.9), 16.2 (+/-2.7), 15.3 (+/-3.4) and 15.2 (+/-4.3) mmHg in T, TMMC, TG and TGMMC eyes, respectively. No intergroup difference was found at either IOP targets. The Kaplan-Meier curves relating to either the < or =21 mmHg or the < or =17 mmHg target IOP did not show significant intergroup differences for complete and qualified success rate. When ePTFE was used, a trend favouring the medium-term survival rate was noted. No adverse reaction to the ePTFE was present, and no membrane extrusion or conjuctival erosion were noted in any cases. Hypotony was significantly more frequent (P = 0.035) in groups without ePTFE. Moreover, the late MMC-related complications were more frequent when MMC was applied.\nCONCLUSION: Expanded polytetrafluoroethylene implant in trabeculectomy is well tolerated and could act as a filtration modulating device. Therefore, it is useful in reducing early hypotony-related complications and contributes to attaining medium-term IOP control that is comparable to the low-dosage MMC."
},
{
"source_pmid": "23113645",
"source_text": "PURPOSE: To compare the results of subscleral trabeculectomy (SST) augmented with mitomycin-C (MMC) versus Ologen™ implant regarding intraocular pressure (IOP) control and incidence of complications.\nMETHODS: Sixty eyes of 60 patients, who planned to undergo SST, were divided into 2 groups. Group I eyes (included thirty eyes) were operated upon with SST augmented with intraoperative MMC. Group II eyes (included 30 eyes) were operated upon with SST using an Ologen implant. IOP and bleb status, as well as reporting postoperative complications, were followed up.\nRESULTS: The follow-up period was 12 months. At 12 months postoperatively, the mean IOP was 19.33±3.22 mmHg in group I, and 19.87±4.17 mmHg in group II, with no significant difference between groups. One case in each group had hyphema, and 4 cases in group I and 2 cases in group II had shallow anterior chamber. One case in group I and no cases in group II had blebitis. There was no significant difference regarding the complications between both groups.\nCONCLUSION: We conclude that the use of the Ologen implant in SST is comparable to the use of MMC with advantage of avoiding the potential dangerous complications related to MMC use in the early (12 months) follow-up period."
}
] |
20179632
| "CONCLUSIONS: Trabeculectomy was found to have a greater pressure-lowering effect compared with visc(...TRUNCATED)
| "AIMS: To compare trabeculectomy with viscocanalostomy augmented with adjunctive antimetabolite use (...TRUNCATED)
| [{"source_pmid":"15258016","source_text":"AIMS: To compare trabeculectomy with viscocanalostomy augm(...TRUNCATED)
|
30666092
| "Compared with ranibizumab, corticosteroid implant did not have greater improved BCVA, but corticost(...TRUNCATED)
| "PURPOSE: To evaluate whether treatment with dexamethasone intravitreal implant (DEX implant) 0.7 m(...TRUNCATED)
| [{"source_pmid":"27632215","source_text":"PURPOSE: To evaluate whether treatment with dexamethasone (...TRUNCATED)
|
32504495
| "State-of-the-art neural networks could effectively detect clinical significant DR. To further impro(...TRUNCATED)
| "IMPORTANCE: More than 60 million people in India have diabetes and are at risk for diabetic retinop(...TRUNCATED)
| [{"source_pmid":"31194246","source_text":"IMPORTANCE: More than 60 million people in India have diab(...TRUNCATED)
|
26966358
| "CONCLUSION: This meta-analysis suggests lower cognitive function test scores in patients with AMD, (...TRUNCATED)
| "Several previous studies showed that age-related macular degeneration (AMD) and Alzheimer's disease(...TRUNCATED)
| [{"source_pmid":"24370621","source_text":"Several previous studies showed that age-related macular d(...TRUNCATED)
|
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