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References | legend: design of the trial.(Individual percentage changes in PPi, comparing the end of the placebo phase and the end of the lansoprazole phase. 20.2% (2.7–31.5%).Clinical characteristics of patients.Data are showed as mean ± SD or N (%). Abbreviation: ABI, ankle–brachial index.Laboratory parameters in the final visits according to the phase of therapy.Abbreviations: PTH, parathyroid hormone; PPi, plasma inorganic pyrophosphate; ENPP1, ectonucleotide pyrophosphatase/phosphodiesterase; TNAP, tissue-nonspecific alkaline phosphatase; CXCL4, platelet factor 4. | PMC10003519 | ||
Methods | obesity | OBESITY | A total of 77 female college students with hidden obesity, aged 18–22 years, were randomly assigned to a control group (CON, | PMC10235762 |
Results | (1) Intragroup comparison before and after the intervention revealed that the TRF, EXE, and TRF + EXE groups had significantly reduced body weight ( | PMC10235762 | ||
Conclusion | obesity | OBESITY | TRF effectively decreased body weight and BMI in female college students with hidden obesity. However, increased blood lipid levels and decreased LTM levels were also observed. The effects of TRF combined with exercise were not superior to those of TRF or walking alone in terms of body weight, body mass index, body composition, TBMD, or blood lipid levels. Therefore, TRF cannot be considered the best option for fat reduction in female college students with hidden obesity. | PMC10235762 |
1. Introduction | obesity, normal-weight obesity | OBESITY | Intermittent fasting (IF), which refers to a dietary intervention that alternates between free eating and fasting, has recently become a popular dietary strategy. Studies have shown that it has many potential benefits for the body (Recently, there has been an increased scientific interest worldwide in hidden obesity. Hidden obesity is also known as normal-weight obesity (This study aimed to evaluate the effects of TRF, walking exercise, and TRF combined with walking exercise in female college students with hidden obesity. The intervention also Additionally, we specifically aimed to explore the effects of TRF and exercise in women with hidden obesity. | PMC10235762 |
2. Materials and methods | PMC10235762 | |||
2.1. Participants | This study enrolled 90 female students aged 18–22 years from Henan University between September 2021 and April 2022. The inclusion criteria were BMI between 18.5 kg/mWe used random number sequences for this group (Flow of participant selection in the study. CON, control; TRF, time-restricted feeding; EXE, exercise; TRF + EXE, time-restricted feeding combined with exercise. | PMC10235762 | ||
2.2. Study design | This was an 8 week ( | PMC10235762 | ||
2.3. Indicator testing | PMC10235762 | |||
2.3.1. Height measurement | The height of the participants was measured by members of the study team. The participants were asked to stand barefoot in an upright position with their heels and forefeet at a 60°angle on a height test meter. The height reading was accurately measured to the nearest 0.01 cm, and the average of three measurements was calculated. | PMC10235762 | ||
2.3.2. Body weight, body composition, and bone mineral density measurements | Dual-energy X-ray absorptiometry, ATM | Dual-energy X-ray absorptiometry (Hologic, Horizon-Wi, United States) was used to evaluate body weight, BF%, adipose tissue mass (ATM), lean tissue mass (LTM), and total bone mineral density (TBMD). A quality assurance procedure was performed prior to testing. The participants were asked to remove any metal objects (such as belts, keys, or cell phones) and lie flat on the testbed with their feet turned inward for scanning. The entire test process took approximately 15 min, and the participants were asked to remain relaxed and avoid moving as much as possible during the test to avoid affecting the test results. | PMC10235762 | |
2.3.3. Blood lipid index data | morning fasting venous blood samples, TG | One day before the start and 1 day after the end of the intervention, early morning fasting venous blood samples were collected from all participants in a standardized manner at the First Affiliated Hospital of Henan University. Total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels were measured. | PMC10235762 | |
2.3.4. Blood pressure measurement | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured using medical automatic electronic blood pressure monitor (Omron, HBP-9020, Japan). Participants were asked to avoid strenuous activity for 1 h before measurement and to rest quietly for 10 min before measurement. The right forearm was placed flat on a table with the palm facing up while the participant was seated, and the pulse pressure band was fastened to the participant’s upper arm with an appropriate amount of tension. The same upper arm was used to record three measurements and the average SBP and DBP readings were recorded as the final blood pressure. | PMC10235762 | ||
2.4. Walking monitoring | An ActiGraph GT3X triaxial accelerometer was used to monitor the participants’ daily step count and energy expenditure. The participants were instructed to wear the accelerometer on their left wrist. Daily steps during the 8 week intervention.CON, control; TRF, time-restricted feeding; EXE, walking exercise; TRF + EXE, time-restricted feeding combined with walking exercise. | PMC10235762 | ||
2.5. Quality control | ADVERSE REACTIONS | To ensure that each participant could apply the TRF approach and walking exercise program independently, a thorough description of both activities was provided to all participants prior to trial commencement. During the intervention, weekly communication was conducted with the participants, and any adverse reactions experienced by the intervention groups were recorded. Participants who experienced serious adverse reactions were asked to discontinue participation. Simultaneously, the research team supervised the intervention by asking the participants to upload their diet and exercise data daily to the WeChat platform to promptly detect problems and provide targeted assistance. | PMC10235762 | |
2.6. Sample size | We used G* Power software (version 3.1.9.7) to calculate the sample size. At least 76 participants were required to achieve a statistical power of 90% at the | PMC10235762 | ||
2.7. Statistical analysis | Experimental data are expressed as means ± standard deviation. The data were tested for normality. One-way ANOVA was used to test for homogeneity between the groups before the intervention and to detect differences in the changes between before and after the intervention. | PMC10235762 | ||
3. Results | PMC10235762 | |||
3.1. Baseline characteristics | No statistically significant differences were found in the participant preintervention baseline indicators among the CON, TRF, EXE, and TRF + EXE groups (Baseline characteristics of the study participants (The data were expressed as means ± standard deviations. CON, control; TRF, time-restricted feeding; EXE, walking exercise; TRF + EXE, time-restricted feeding combined with walking exercise; BMI, body mass index; BF%, body fat percentage; ATM, adipose tissue mass; LTM, lean tissue mass; TBMD, total bone mineral density; TC, total cholesterol; TG, triglyceride; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; DBP, diastolic blood pressure; SBP, systolic blood pressure. | PMC10235762 | ||
3.2. Changes in body weight and body mass index | After the 8 week intervention, intragroup comparisons revealed that participants in the TRF, EXE, and TRF + EXE groups showed significant reductions in both weight and BMI (Changes in the health indicators of the participants before and after intervention.In the intra-group comparison, * indicates After the 8 week intervention, intergroup comparisons revealed that the change in weight was significantly higher in the TRF (Changes in body weight and body mass index after the 8 week intervention. The changes were expressed as means ± standard error and were calculated by subtracting the 8 week value from the baseline value. | PMC10235762 | ||
3.3. Changes in body composition and bone mineral density | After the 8 week intervention, the intragroup comparison revealed that the BF% increased significantly in the EXE and TRF + EXE groups (After the 8 week intervention, BF% showed a positive change in all groups, but the TRF group showed the smallest change (Changes in the body composition and total bone mineral density after the 8 week intervention. Changes are expressed as means ± standard errors and calculated by subtracting the 8 week value from the baseline value. | PMC10235762 | ||
3.4. Changes in blood lipid levels and blood pressure | After the 8 week intervention, the intragroup comparison revealed that TC levels increased significantly in the TRF, EXE, and TRF + EXE groups (As shown in Changes in the blood lipid levels and blood pressure after the 8 week intervention. Changes are expressed as means ± standard errors and calculated by subtracting the 8 week value from the baseline value. | PMC10235762 | ||
3.5. Adverse reactions | ADVERSE REACTIONS, MINOR, ADVERSE REACTIONS | No serious adverse reactions were reported in the participants in the three intervention groups; however, the number of participants experiencing minor adverse reactions was higher in the TRF (57.9% of participants), and TRF + EXE (78.9%) groups than in the EXE group (40%) (Adverse reactions of the participants during the intervention.TRF, time-restricted feeding; EXE, walking exercise; TRF + EXE, time-restricted feeding combined with walking exercise. | PMC10235762 | |
4. Discussion | Obesity | OBESITY | Obesity is a global public health issue that is attracting widespread public attention. The TRF dietary pattern allowed participants to reduce their energy intake ( | PMC10235762 |
4.1. Effect of time-restricted feeding and walking exercise on body composition of hidden obesity in female college students | obesity, eating behaviors, weight loss, Eating behavior | OBESITY | This study found that after the 8 week intervention, the BF% of the participants in the TRF and TRF + EXE groups increased considerably; in the EXE and TRF + EXE groups, LTM decreased significantly after the 8 week intervention. These results indicate that among female college students with hidden obesity, the 8 week TRF and walking exercise intervention had a negative impact on BF% and LTM. Although studies have shown that TRF has many health benefits, its effects on weight loss in humans remain controversial (Another reason for the results of this study may be attributable to the eating behaviors of college students. Eating behavior is an important factor influencing the development of hidden obesity (Additionally, walking is a low-intensity and prolonged aerobic activity (It is important to note that even though the weight of the participants in the intervention groups showed a declining trend, the reduction in LTM was the main reason for weight loss caused by TRF, resulting in an increased BF% in the subjects. Therefore, measures are required to compensate for this effect on the LTM. The effect of resistance exercise on reducing BF% and increasing LTM in participants should be properly considered ( | PMC10235762 |
4.2. Effect of time-restricted feeding and walking exercise on BMD of hidden obesity in female college students | obesity | OBESITY | In this study, there were no significant differences in TBMD between the TRF, EXE, and TRF + EXE groups before and after the intervention. Increased fat and reduced muscle mass are characteristics of individuals with hidden obesity. Excess fat also has a negative impact on bone mineral density ( | PMC10235762 |
4.3. Effect of time-restricted feeding and walking exercise on blood lipids of hidden obesity in female college students | This study found that after the 8 week intervention, participants in different intervention groups showed varying degrees of elevated blood lipid levels. This suggests that the study intervention had a negative effect on lipid levels. To date, it has not been conclusively demonstrated whether TRF lowers blood lipid levels in humans. According to several studies, TRF simply modifies the timing of food intake and does not change the diet composition; hence, such eating practices can result in abnormal blood lipid levels ( | PMC10235762 | ||
5. Limitations | DISEASES | This study presents some limitations. First, the sample size was small and the intervention period was short. Further studies should be conducted involving large samples and over long periods of time. Second, relevant indicators were not tested for the 4 week intervention outcomes. Moreover, some indicators, such as blood glucose and fasting insulin levels, were not tested. A greater understanding of time-restricted eating patterns is required, including the optimal duration and frequency of fasting, long-term compliance, and their effect on reducing various diseases. Furthermore, in view of the heterogenous findings reported to date, the effects of time-restricted eating in different healthy populations needs to be clarified in future studies. | PMC10235762 | |
6. Conclusion | obesity | OBESITY | Although TRF reduced body weight and BMI in the participants of this study, it also resulted in an increase in blood lipid levels and loss of LTM. In terms of body weight, BMI, body composition, TBMD, and blood lipid levels, TRF combined with walking exercise did not achieve better results than TRF or walking exercise alone. Therefore, TRF cannot be considered as the best option for fat reduction and obesity prevention in female college students with hidden obesity. | PMC10235762 |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author. | PMC10235762 | ||
Ethics statement | HUSOM2021 | The studies involving human participants were reviewed and approved by This project was approved by the Ethics Committee of Human Research of Henan university (HUSOM2021-210). The patients/participants provided their written informed consent to participate in this study. | PMC10235762 | |
Author contributions | HL | HL: conceptualization, validation, writing—review and editing, supervision, and project administration. HL and SC: methodology, formal analysis, and writing—original draft preparation. SC and HJ: software. SC, HJ, and ZD: investigation. ZD and SC: data curation. SC: visualization. All authors contributed to the article and approved the submitted version. | PMC10235762 | |
Funding | This research was funded by the Henan Science and Technology Development Project (grant number 202102310320), the Kaifeng Science and Technology Development Project (grant number 2003006), the Postgraduate Cultivating Innovation and Quality Improvement Action Plan of Henan University (grant number SYL-AL2022011), and the Henan University Teaching Reform Project (grant number HDXJJG2021-152). | PMC10235762 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10235762 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10235762 | ||
References | PMC10235762 | |||
Purpose | LENS | The aim of this study was to deduce theoretically and verify the resolution limit of human eye to spherical lens change for more reasonable design of the trial lenses. | PMC10113289 | |
Methods | MYOPIA | A total of 119 normal subjects with different myopia (not more than − 6D) were included. First, the resolution limit of discernible change in spherical power was derived based on the optical model. Then, the subjects were observed to see if they could perceive the changes in spherical power as per the resolution limit and compare the difference in the best-corrected visual acuity obtained with the resolution limit and interval of 0.25D. | PMC10113289 | |
Results | diopter | LENS | Assuming that the cone cell diameter is 3 μm and the pupil diameter of 4 mm, the theoretically resolution limit was 0.05D. When the diopter of spherical power was increased, the ratios of ability to perceive 0.05D spherical lens change were 98.3% and 96.7% in right and left eyes. When the diopter of spherical power was decreased, the ratios of ability to perceive 0.05D spherical lens change were 78.9% and 83.2% in right and left eyes. The best-corrected visual acuity obtained with the 0.05 D interval trial lens was significantly better than in the 0.25 D interval on both eyes (Right eye − 0.04 ± 0.07 vs − 0.02 ± 0.06, | PMC10113289 |
Keywords | PMC10113289 | |||
Introduction | overcorrection, myopia, undercorrection | MYOPIA, LENS | In the information age, the prevalence of myopia among adolescents is increasing year by year, evidenced by up to 80% of myopia among Chinese high school students. Frame glasses are still the main method for myopia correction. Previous studies have shown that overcorrection or undercorrection will lead to the accelerated progression of myopia. Spherical-power full correction is recommended for adolescent myopia [From the middle of the nineteenth century to the early twentieth century, the interval of spherical-power trial case lenses was reduced from 1D to 0.25D and has been used up to now. However, we have not found the theoretical basis for setting the interval at 0.25D, which may be related to the cost of lens manufacturing at that time. In order to determine the adjustment interval of spherical-power lens more scientifically and reasonably and help patients get better visual quality, this study firstly calculated the theoretically derived resolution limit of human eye to spherical lens change based on the optical model, and then observed the actual resolution values of volunteers to compare the two for any consistency. | PMC10113289 |
Materials and methods | PMC10113289 | |||
Calculation of the theoretically derived resolution limit of human eye to spherical lens change | diopter | Let the diopter of a human eye optical model be A (D), the diameter of human cone cell B (μm), and the pupil diameter The optical model of minimum limit of discernible change in spherical powerBy substituting the total diopter of human eye, the diameter of cone cell and the pupil diameter in Formula ( | PMC10113289 | |
Clinical validation of the resolution limit of human eye to spherical lens change | PMC10113289 | |||
Study participants | astigmatism, myopia | ASTIGMATISM, MYOPIA | The data were prospectively collected from myopia volunteers who visited Beijing Tongren Hospital from September 2020 to September 2021. The research was approved by the Human Studies Committee at Beijing Tongren Hospital (Beijing, China) in accordance with the Code of Ethics of the World Medical Association (registration number: ChiCTR2100047074). Subjects signed a statement of informed consent prior to their participation in the study. Patient’s inclusion criteria were as follows: (1) patients with myopia not more than − 6D, with corrected visual acuity≧1.0; (2) those having astigmatism with rule and | PMC10113289 |
Examination procedures | PMC10113289 | |||
Adjust the spherical power at an interval of 0.25D to find the red-green balance point | confusion | CROSS, RETINA | Standard subjective refraction was performed using a standard phoropter. The monocular best vision sphere was determined using the Duochrome chart to ensure the circle of least confusion was on the retina before conducting Jackson Cross Cylinder (JCC). The circle of least confusion was maintained on the retina as cylinder power was increased. Once cylinder power and axis were calculated, the sphere was refined to best-corrected visual acuity (BCVA) with minimum minus power. Binocular balance using alternate occlusion technique was then conducted to best binocular VA to BCVA with minimum minus power.Binocular balanced refraction results were placed in a trial frame and the eye not being tested was occluded. Subjects were asked to give a response as to whether the letters on the red or green side of the Duochrome were clearer. If the subject reported the red side being clearer, minus power was added in 0.25D steps until equality between red and green was achieved. If the subject reported the green side being clearer, then plus 0.75D was added so that red became clearer. The same step as previously described for when the side was clearer was then performed. The final sphere was where equality was first achieved between the red and green letters of the Duochrome. If equality could not be achieved, then the final sphere was the point where the next 0.25D change made green clearer. The final sphere, and previously calculated cylindrical power and axis were recorded for the final prescription. | PMC10113289 |
Verify the resolution limit of change in spherical power | diopter | Starting from the diopter of red-green balance point of equal clarity obtained by adjusting the spherical power at an interval of 0.25D, the diopter of spherical power was increased and decreased by one time of resolution limit, respectively. The volunteers were asked for any changes in the clarity of the red and green optotypes either from equal clarity to green clarity or red clarity. If there was no change, the point of equal clarity was used as the starting point again, and the diopter of spherical power was changed by 2 times the resolution limit. The volunteers were then asked for any changes in the clarity of optotypes. If still no change, the point of equal clarity was taken as the starting point to further increase the range of changes in the diopter of spherical power (an integer multiple of the resolution limit) until the clarity of optotypes changed.In case of failure to identify the red-green balance point of equal clarity by adjusting the spherical power at an interval of 0.25D, the maximum diopter of red clarity (an increase of − 0.25D to be green clarity) should be taken as the starting point, and the resolution limit as the interval to find the point of equal clarity. After identifying the point of equal clarity, the limit of differences in the visually resolved diopter of spherical power could be validated following the above steps. If the point of equal clarity was still not found at the interval of the resolution limit, the diopter of spherical power was increased by one time the resolution limit from the maximum diopter of red clarity to get green clarity, and the volunteer's resolution limit was denoted as 1/2 of the resolution limit.The prescription and the best-corrected visual acuity were obtained by adjusting the spherical power at an interval of 0.25D and the resolution limit, respectively. The prescription of spherical power was determined according to the following principles: In case of a red-green balance point, the diopter of equal clarity is taken as the prescription diopter of spherical power. In absence of the red-green balance point, the maximum diopter of red clarity is taken as the prescription diopter of spherical power. The two sets of trial case lenses were of the same substrate material, manufacturing process and manufacturer (Minghao Technology (Beijing) Co., Ltd.). The visual acuity chart was an international standard one, and the recorded values were converted to the logarithm of the minimum angle of resolution (LogMAR). | PMC10113289 | |
Statistical analysis | Before study initiation, we calculated the necessary sample size to ensure feasibility, we recruited 30 volunteers to observe the resolution limit of discernible change in spherical power. The mean resolution limit of change in spherical power was 0.05 ± 0.01. The test level was 0.05 and the test power was 0.80, 110 volunteers were needed based on the following sample size calculation formula. (SPSS 20.0 (IBM, Armonk NY) statistical software was used for analysis. Statistical significance was set at p ≤ 0.05. For continuous variables, data are presented as mean ± SD. Distributional normality was tested between different groups. The single-sample t-test was used to compare the theoretically derived resolution limit and the actual resolution, and the paired | PMC10113289 | ||
Patient and public involvement | No patients or the public were involved in the study protocol design, the specific aims or the research questions, and the plans for the design or implementation of the current study. No patients or the public were involved in the interpretation of the results of the study or preparation of the manuscript. There are no plans to disseminate the results of the research to study participants. | PMC10113289 | ||
Results | PMC10113289 | |||
The theoretically derived resolution limit of human eye to spherical lens change | diopter | When the total diopter of a human eye was 60.00D, the diameter of cone cell of 3 μm [ | PMC10113289 | |
Clinical validation of the theoretically derived resolution limit of human eye to spherical lens change | powerAs, diopter | As shown in Table Basic information of included volunteersThe resolution limit that volunteers can resolve is shown in Table Limit of discernible change in spherical powerAs shown in Table Distribution of the resolution limits for changes in the actually resolved diopter of spherical powerTable Prescription and corrected visual acuity for adjusting spherical power at 0.25D and 0.05D | PMC10113289 | |
Author Contributions | All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [ZY], [GJ] and [DY]. The first draft of the manuscript was written by [ZY] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. | PMC10113289 | ||
Funding | This work was supported by the Beijing Advanced Innovation Center for Big Data-Based Precision Medicine and Beijing Municipal Science and Technology Project (Z201100005520042). | PMC10113289 | ||
Declarations | PMC10113289 | |||
Competing interests | The authors declare no competing interests. | PMC10113289 | ||
Conflict of interests | The authors have no relevant financial or non-financial interests to disclose. | PMC10113289 | ||
Ethics Approval | This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Beijing Tongren Hospital B (2019/05/30, TRECKY2018-028).” | PMC10113289 | ||
Consent to participate | Informed consent was obtained from all individual participants included in the study. | PMC10113289 | ||
Patient consent | Obtained. | PMC10113289 | ||
References | PMC10113289 | |||
Background | This study aims to assess the influence of using 3D-printed acrylic resin versus conventional Poly-methyl methacrylate (PMMA) for fabricating ocular prostheses on the biofilm and microbial flora of anophthalmic socket. | PMC10729395 | ||
Methods | A randomized controlled trial was designed as a parallel group study. Participants were allocated randomly into two groups: the control group, which received conventionally fabricated ocular prostheses (CG, | PMC10729395 | ||
Results | Test group (DG, | PMC10729395 | ||
Conclusions | The choice of ocular prosthesis fabrication technique did not yield a statistically significant difference in anophthalmic flora. However, the 3D-printed acrylic resin, as an artificial eye material, displayed potential advantages in reducing the colonization of opportunistic pathogens. All subjective clinical evaluation parameters exhibited enhanced outcomes after three months of prosthesis use, emphasizing the need for an adaptation period during which patients complains are alleviated. In comparison with PMMA, 3D-printed acrylic resin showcased a certain degree of anti-colonization ability against pathogenic bacteria, along with a significant level of patient comfort, suggesting its potential as a promising material for ocular prostheses. | PMC10729395 | ||
Trial registration | This parallel double-blinded RCT has been registered at ClinicalTrials.gov with identification number: NCT05584865, 18/10/2022. | PMC10729395 | ||
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10729395 | ||
Background | eyeball deformities, palpebral muscle tone, infections, CAD, orthodontic, denture, palpebral collapse | CNS INFECTIONS, INFECTIONS, PATHOPHYSIOLOGY, CAVITY, CONJUNCTIVA, CAD | The objectives of treating anophthalmic patients with ocular prostheses are to restore facial aesthetics and self-esteem. This involves repairing eyeball deformities, protecting the anophthalmic cavity, preserving the palpebral muscle tone, inhibiting palpebral collapse, restoring lachrymal direction, and preventing the accumulation of lachrymal fluid within the eye cavity [However, wearers of ocular prostheses encounter varying degrees of comfort. Often, they exhibit symptoms of chronic discharge and irritation. Several factors have been proposed as underlying causes of these issues. One such factor is the alterations that occur in the conjunctival flora after enucleation and subsequent use of ocular prostheses [Numerous studies have investigated the microbial composition of the conjunctival flora within the anophthalmic cavity. The majority of these studies have demonstrated higher rates of pathogens in the socket compared to the normal conjunctival flora [These conspicuous changes in the socket flora may arise due to modifications in the conjunctival epithelium following enucleation or evisceration surgery. The absence of the globe and the use of an artificial eye led to various alterations on the ocular surface. Firstly, the bulbar conjunctiva is no longer swept by the eyelids. Secondly, the ocular prosthesis, functioning as a foreign body, can cause frictional irritation of the conjunctiva during its movement [Furthermore, the presence of dead space [A significant advancement in the realm of customized ocular prostheses is the utilization of digital technology, including Computer-Aided Designing (CAD) and Computer-Aided Manufacturing (CAM), which hold the key to creating accurate and aesthetically pleasing ocular prosthesis. Few studies have explored the construction of digital ocular prostheses, all of which have shown promising results in terms of aesthetics, fit, and patient satisfaction [Finally, some studies suggest that the material and surface roughness of ocular prosthesis can influence interactions with microorganisms, potentially leading to the establishment of biofilm bacteria, which may, in turn, result in infections. As for the material used in the fabrication of ocular prostheses, thermally activated acrylic resin remains the most commonly employed material in clinical practice [Acrylic resin is the most commonly used material for fabricating artificial eyes due to its excellent physical and mechanical properties [Poly-methyl methacrylate (PMMA) is another material used, but it has its drawbacks. It is a porous material that is prone to microbial biofilm accumulation [With the introduction of computer-aided design and computer-aided manufacturing (CAD/CAM) technology in the fabrication of ocular prostheses, 3D-printed acrylic resin has become a notable material choice. Generally, 3D-printed resins show promise for clinical applications due to their improved mechanical and physical properties, making them suitable for replacing conventional fabrication techniques [Several studies have compared the different properties of 3D-printed photopolymerized resin to conventional PMMA resins in applications such as denture bases, temporary crowns, and orthodontic appliances [Therefore, this study aims to evaluate the microbiological properties of digitally designed 3D-printed biocompatible resins in comparison to conventionally manufactured heat-cured acrylic resin, which is the most commonly used material for ocular prostheses. The objective is to gain a better understanding of the pathophysiology of infections in the anophthalmic cavity when using different types of ocular prostheses designs and materials. The null hypothesis of this study posits that there is no difference between the microbiotas of anophthalmic socket after use of both types of ocular prostheses material. | PMC10729395 |
Methods | PMC10729395 | |||
Study setting | This clinical and microbiological comparative study took place at the Department of Prosthodontics, Faculty of Dentistry, and the Department of Microbiology, Medical Research Institute, Alexandria University. This trial has been registered at ClinicalTrials.gov with identification number: NCT05584865, registration date: (18/10/2022). The authors certify that this trial has received ethical approval from the Research Ethics Committee, Faculty of Dentistry, Alexandria University, Egypt (international No.: IORG0008839, ethics committee number: 0441–6/2022; date of registration: 9/6/2022). Signed written informed consent forms were obtained before enrollment in this trial. | PMC10729395 | ||
Sample size calculation | The sample size was calculated with 5% alpha error and 80% study power. Hashem et al. [ | PMC10729395 | ||
Inclusion and exclusion criteria | psychological disorder | EYE INFECTION, SYSTEMIC DISEASE | All subjects enrolled in the study had unilateral anophthalmic socket. The subject-related inclusion criteria were: (i) age range between 19 and 65 years; (ii) Had enough ocular bed to accommodate the ocular prosthesis; (iii) At least 3 months after surgery to allow complete healing of the socket. Subjects were excluded if they were: (i) Under steroid therapy or those under radio or chemotherapy; (ii) had eye lid deformity; (iii) Had history of psychological disorder or systemic disease.; (iv) had eye infection. | PMC10729395 |
Study design | This is a randomized, parallel control trial with two balanced parallel arms, following the CONSORT checklist [
Flow diagram of study design following CONSORT guidelinesAfter obtaining informed consent and a patient’s medical history, epidemiological data of interest were collected including age, gender, eye loss, etiology of eye loss, and occupation as presented in (Table
Patient demographic data for group I and IIParticipants were randomly assigned to two equal groups. Group I, the control group (CG, | PMC10729395 | ||
Ocular Prosthesis Fabrication in Group I (Conventional Method) | SCLERA | In the case of Group I, a conventional custom-made ocular prosthesis was created following the original technique described by Cain [For the iris disk (Factor II Inc., Lakeside. AZ, USA) was utilized and painted using oil pigments (Gouache oil, Northampton, USA) or earth pigments dissolved in a solvent such as monopoly to achieve the same color as the iris of patient’s healthy eye. A 1 mm reduction was made from the scleral surface to create space for a layer of clear acrylic resin. Subsequently, the sclera was painted and characterized to mimic the appearance of the sclera of the contralateral eye. The iris disk was positioned precisely in the previously determined iris position, and a layer of clear, heat-cured acrylic resin was applied to encapsulate the assembly. The ocular prosthesis was then meticulously finished, polished and subsequently delivered to the patient (Fig.
Flasked ocular prosthesis fabricated from PMMA | PMC10729395 | |
Ocular Prosthesis Fabrication in Group II (Digital 3D-Printed Ocular Prosthesis) | CAD | SCLERA, CAD | In group II, a digitally designed 3D-printed ocular prosthesis was created. A Computerized Tomography (CT) scan image for the orbit was obtained, providing detailed information about the anophthalmic socket in a layered format. Digital Imaging and Communications in medicine (DICOM) data from the CT scan were imported into Materialise’s Interactive Medical Image Control System (MIMICS) software for the segmentation process. This process separates the soft tissue bed of the socket from the eyelids of the affected eye, revealing the fitting surface of the socket. This method replaces the conventional impression technique.The data was then imported into a 3-Matic software (Materialise 3-matic. CAD link module. Montreal, QC) to create a mid-sagittal plane. A mirrored image of the normal eyeball was used as a reference for the design and construction of the ocular prosthesis for the affected eye. Subtraction the mirrored normal eyeball from the defective eyeball was performed, resulting in the digitally designed ocular prosthesis.The STL was printed using medical-grade 3D-printed acrylic resin (Preform; Formlabs, USA) on a Formlabs, Form 2 printer (Formlabs, Somerville, USA). This printer operates based on SLA technology with a 405 nm laser wavelength and a layer thickness 50 μm. To ensure that finished parts are biocompatible we followed wash setting and post cure setting as noted in the Instructions for Use, prosthesis washed in 99% isopropyl alcohol for 10 min, then post cured for 60–90 min in 80 °C.The iris was printed using high-quality patient photographs through UV printing technology, utilizing a Roland Versa UV LEF-200 printer (Roland DG Corp., Japan). Subsequently, conventional sclera characterization was done performed, and layer of clear PMMA was added to cover the sclera, the ocular prosthesis was then finished, polished and delivered to the patient (Fig.
3D-printed ocular prosthesis using medical grade 3D-printed acrylic resin (Preform; Formlabs, USA) | PMC10729395 |
Subjective clinical evaluation (Questionnaire) | dryness, pain | A validated questionnaire was employed to assess the comfort level of the patients. Prior to its use, the questionnaire underwent pilot testing with six prosthodontics experts who were involved in the study. These experts assessed both the content and face validity of the questionnaire. The content validity index per item ranged from 0.83 to 0.99, with an overall content validity score of 0.93 [Patients were requested to rate their comfort level in one of three categories: “bad”, “good”, or “excellent”. The absence of pain or discomfort was classified as “excellent”; mild discomfort as “good”, and moderate to severe discomfort was considered as “bad”.Socket discharge was categorized into three levels: mild, moderate, and severe, based on the amount of discharge observed. Lacrimation was assessed with a simple “yes” or “no” response. Similarly, lubrication frequency was categorized as “frequent” or “not frequent”. An increased need for lubrication indicated dryness and discomfort. Patients requiring lubrication 2–3 times daily were classified as “not frequent”, while those needing lubrication more than three times daily were classified as “frequent”. | PMC10729395 | |
Microbiological analysis | non-lactose | FRANKLIN, BRAIN, STERILE, CAVITY, STERILE, HEART, CONJUNCTIVA | Swabs for microbiological evaluation were collected from the conjunctiva of the defective socket in both groups before the insertion of the prosthesis and again three months later, following the removal of the artificial eye using a suction cup. Prior to sample collection, patients were instructed not to use antibiotics, either topically or systemically, for at least five days before the sample collection and to retain from washing the area with any antiseptic solution other than saline.Sterile rayon swabs (Rayswab, Difco) were soaked in 9% sodium chloride from the inferior fornix of the anophthalmic cavity. Each swab was then cut off and placed in a tube (Becton, Dickinson & Company, Franklin Lakes, NJ, USA) containing 4 mL of sterile Brain Heart Infusion Broth (BHI). The tube was sealed, and cultures were promptly transported to the laboratory.Isolates were identified through microscopy, culture methods, and biochemical tests. The samples underwent the procedures of conventional microbiology diagnostic method [After 48 h incubation the colonies appeared will be subjected to biochemical tests to be identified. For isolates grew on blood agar only gram film from colonies was done and gram positive cocci was further identified using catalase test, bile esculine test, side and tube coagulase test.For isolates grew on blood agar and macck agar gram stained film was done to confirm that it is a gram negative bacilli and the biochemical tests were done (TSI triple sugar iron agar, urease test, citrate test, and MIO-test) for non-lactose fermenting colonies oxidase test was added.Gram stain film from colonies appeared on SDA was done. After the prescribed incubation period, the identification of the isolate was carried out through Gram staining, microscopy, and biochemical reactions. | PMC10729395 |
Blinding | BLIND | A double-blinding strategy was employed in this trial. Both the patients and evaluators were blinded. Evaluators were blinded because pre-prosthetic and post-prosthetic swabs were taken when the prosthesis was not present in the socket. Because the construction methods employed for the conventional and digital ocular prostheses are totally different, it was impossible to blind the operators. | PMC10729395 | |
Statistical analysis | Descriptive statistics were calculated as frequencies and percentages. Comparisons of microbial growth between the two study groups were conducted using the Fisher exact test. The McNemar test was employed for comparisons of microbial growth before and after the intervention within each group. Intention-to-treat analysis was used for analyzing all subjects in the current study. Significance was set at | PMC10729395 | ||
Results | Based on the inclusion and exclusion criteria, 22 patients were included in this clinical trial, 11 in each group. After a 3-month follow-up, the data were collected and applied for the statistical analysis. All patients completed the study without dropping out of any patient after randomization. | PMC10729395 | ||
Questionnaire | A statistically significant difference was recoded regarding the level of comfort between the two groups, both after one week of prosthesis insertion (
Comfort levelAs for discharge rating, there was no statistically significant difference observed between both groups, either after one week of prosthesis insertion (
Discharge rating
Discharge location
Lacrimation
Lubrication frequencyRegarding discharge location, no statistically significant difference was recorded (Fig. Concerning lacrimation, no statistically significant difference was noted, although most patients in both groups showed improvement in lacrimation after three months of prosthesis use (Fig. In terms of lubrication frequency, there was no statistically significant difference between both groups. However, the needed lubrication frequency decreased after three months of prosthesis use in both groups (Fig. | PMC10729395 | ||
Discussion | Enterococci, P. aeruginosa, Candida albicans, Depressions, Candida albicans yeast, S. aureus | PROSTHETIC INFECTION, PROLIFERATION, ADHESION, CAVITY, PSEUDOMONAS, KLEBSIELLA, HEAT | While various factors can influence the comfort level of ocular prosthesis patients, the disturbance of ocular flora may be the most crucial factor affecting their ocular comfort. Previous studies have examined changes in microbial flora within anophthalmic sockets. However, the majority of these studies focused on comparing the flora of the anophthalmic socket with that of a healthy eye [All of these studies have reported a higher level of microorganism formation in the anophthalmic cavity and ocular prosthesis compared to the contralateral eye. This increased presence was observed for total bacteria, S. aureus, S. epidermidis, and Candida albicans. Staphylococcus species are significant pathogens associated with prosthetic infections. Furthermore, the anophthalmic cavity provides an ideal environment for the proliferation of undesirable fungi, especially Candida albicans yeast [Some studies have examined the effects of various cleansing methods, the frequency of ocular prosthesis manipulation, the age of the ocular prosthesis, the frequency of polishing, and the administration of antibiotic eye drops on the flora of the socket and ocular prosthesis biofilm [Since all patients in both groups received their prostheses for the first time and were assessed three months later to eliminate the age of the prosthesis as a factor, all patients in our study underwent the same cleaning procedures for their ocular prostheses. This cleaning regimen included washing them with water and soap once a week. Furthermore, none of the prostheses were polished within the first three months of use, and all patients were instructed not to use antibiotic eye drops.A number of earlier studies [The results of the current study showed a lower percentage of microbial growth in Group II (digitally designed 3D-printed) ocular prostheses, with (72.7) % of sockets showing no growth after three months of prosthesis use. This is in contrast to a higher percentage of microbial growth observed in Group I patients (conventional heat cured PMMA). Although Group II shows positive results, there is no statistically significant difference between the two groups and the null hypothesis was accepted. We observed a positive correlation between the material and design of the prosthesis and changes in microbial flora. This could be explained by the effect of surface roughness, which is considered one of the key factors influencing the adhesion and colonization of microorganisms on biomaterials. Depressions, micro-cracks and porosities in roughened surfaces provide more favorable colonization sites [The findings of the current study, along with those of previous studies, clarify that Group II patients have significantly higher levels of comfort than Group I patients. Group II patients also experience less discharge, although both groups’ discharge rates started to decline after three months of use.In contrast, some studies have reported opposing results. Teixeira et al. [Another important factor in reducing microbial growth is the fit and design of the ocular prosthesis, which plays a crucial role in eliminating dead space between the prosthesis fitting surface and the anophthalmic socket. This eliminates the accumulation of secretions and creates an environment less favorable for microbial growth. The lower percentages of microbial growth in Group II can be explained by the precision of 3D-printing and software design technology, as reported by other authors who found that 3D-printed restorations exhibited higher accuracy and better fit. Aldahian et al. [The insignificant difference between the two groups may be attributed to the hydrophobicity of both materials. Several studies have demonstrated the importance of the material’s hydrophobic effect on initial adhesion, showing a linear correlation between an increase in hydrophobicity and the number of attached cells [Pseudomonas spp. were recorded in the post-prosthetic swabs of four patients, two from Group I (CG) and two from Group II (DG). However, their pre-prosthetic swabs were free from Pseudomonas spp. This can be primarily attributed to the socio-cultural environment of the patients, which is directly related to their hygiene habits. This airborne bacterium is mainly introduced to the socket during manipulation of the prosthesis with inadequate hygienic habits of the patients. These habits are not only related to their socio-economic status but may also be influenced by their occupation [P. aeruginosa can also effectively colonize a variety of surfaces, including most medical materials, and is a well-known biofilm former. This biofilm acts as a scaffold for adhesion to the prosthesis surface and protects it from the surrounding environment. Biofilms of P. aeruginosa are composed of polysaccharides and extracellular DNA, which play critical roles in protecting the bacterial communities from exogenous stresses caused by antimicrobial agents [In Group I, two patients had positive pre-prosthetic swabs. One had Klebsiella spp., and the other had Enterococci. However, both had negative post-prosthetic swabs. This can be explained by considering both patients as treated individuals who used prophylactic antibiotic eye drops prescribed during the first week of prosthesis use.The limitation of this RCT was the short follow-up period restricted to 3 months. More RCTs are needed with longer follow-up periods to allow for evaluation of long term effect of the material and design of 3D-printed ocular prosthesis on the health of the anophthalmic socket. | PMC10729395 |
Conclusions | From the current study we can conclude the following:
Digitally designed 3D-printed customized ocular prosthesis are considered a successful treatment modality for treating anophthalmic patients.Patients with 3D-printed ocular prostheses had a lower percentage of microbial growth in their sockets compared to the conventional PMMA wearers, although the difference was not staistically significant. However, patients with digital prostheses reported significantly higher comfort levels than conventional prosthesis wearers.Regardless of the construction method, all patients require an adaptation period with their prostheses. Over time, they all show improvements in terms of comfort, discharge, lacrimation, and the need for lubrication. | PMC10729395 | ||
Authors’ contributions | MEA | YAT, FSM, SAE and MEA contributed to conceptualization, methodology. YAT contributed to data collection, curation, material preparation and analysis of the laboratory data. SAE supervised processing of microbiological samples, analysis and acquisition of microbiological data. MEA contributed to interpretation of data. YAT contributed to writing original draft preparation, writing review and editing final manuscript. All authors contributed to critical revision and approval of the final manuscript. | PMC10729395 | |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). The authors did not receive any funding for this study. | PMC10729395 | ||
Availability of data and materials | The datasets used and analyzed during the current RCT are available from the corresponding author upon reasonable request. | PMC10729395 | ||
Declarations | PMC10729395 | |||
Ethics approval and consent to participate | This study was approved by The Research Ethics Committee, Faculty of Dentistry, Alexandria University, Egypt (international No.: IORG0008839, ethics committee number: 0441-6/2022; date of registration: 9/6/2022). All patients were informed about the treatment and signed informed consent forms before enrollment in this trial. All methods were conducted in accordance with the Declaration of Helsinki and ethical guidelines adopted by the Research Ethics Committee of Alexandria University Faculty of Dentistry. | PMC10729395 | ||
Consent for publication | Not applicable. | PMC10729395 | ||
Competing interests | The authors declare no competing interests. | PMC10729395 | ||
References | PMC10729395 | |||
Background | INFECTIOUS DISEASE | Disclosure of infectious disease status to social network peers can facilitate reaching and early detection among high-risk populations. In this era of social media, globally, HIV/AIDS represents a high burden of infectious disease. Thus, delivery of an HIV result e-report via social media presents a new approach that has the potential to improve contact with and enrollment of the high-risk population in research studies and routine practice. | PMC10337306 | |
Objective | WeChat-based | RECRUITMENT | This study explores the effectiveness and associated factors of a recruitment strategy (ie, WeChat-based HIV e-report delivery in social networks) on the enrollment of men who have sex with men (MSM) for an HIV testing intervention study. | PMC10337306 |
Methods | ’ transformation, MSM | EVENTS, RECRUITMENT | This was an enrollment result analysis of an ongoing cluster randomized controlled trial (RCT) aiming to promote HIV testing among MSM. Recruitment of potential participants was based on the unit of an egocentric social network, which includes 1 core member (an offline tested ego as the recruiter) and several network members (online alters as network associates). Alters’ enrollment and alters’ transformation to ego-recruiters (alter-ego) were measured as outcomes. Recruitment outcomes were compared between the exchangeable and regular e-report groups of the RCT. Associated factors of both outcomes were also investigated, including sociodemographic characteristics, health behaviors, social network characteristics, e-report types, and online delivery information. Binary outcomes were modeled using logistic models, with Firth correction for rare events. Qualitative interviews were conducted to understand facilitators and barriers in detail for alter-ego as the subsequent wave’s recruiter. | PMC10337306 |
Results | ’ transformation, alter-egos | RECRUITMENT | The e-report of 1157 egos who tested offline were delivered to 5165 alters in 3 recruitment waves; eventually, 1162 eligible alters enrolled in this RCT (response rate: 22.5%). In the exchangeable e-report group, 544 egos recruited 467 alters, of which 35 alters transformed to alter-egos (7.5%), whereas in the regular e-report group, 613 egos recruited 695 alters, of which 40 alters transformed to alter-egos (5.8%). Alters’ enrollment at first wave was associated with a higher number of e-reports being forwarded by the egos. Alters’ transformation to alter-egos for the subsequent wave was associated with the exchangeable e-report, higher income, being a Guangzhou resident, unprotected anal intercourse, preferring self-testing, and viewing senders’ e-reports frequently. Qualitative interviews revealed that the lack of awareness of e-reports’ function and inadequate access to e-reports at offline testing facilities were major barriers to alters’ transformation to offline ego-recruiters. | PMC10337306 |
Conclusions | infectious diseases, MSM | INFECTIOUS DISEASES, RECRUITMENT | The delivery of e-report was feasible in MSM social network, and the success and sustainability of online recruitment depended on high levels of familiarity among MSM with the digital tool. The HIV e-report exchange mechanism might promote MSM to test HIV offline to get their own e-report for exchange in the community. The e-report provides an innovative recruitment method with great potential to trace direct contacts for infectious diseases studies. | PMC10337306 |
Introduction | infectious diseases, HIV testing [ | INFECTIOUS DISEASES, RECRUITMENT | Controlling the spread of viruses, such as HIV, is essential for preventing and managing infectious diseases [Enhancing internal demand for HIV testing services and interventions is essential for the successful and sustainable scaling up of HIV testing. To achieve this goal, community engagement plays a critical role. It is widely recognized that fulfilling one’s sexual needs is a fundamental aspect of life, and community-driven efforts aimed at reducing HIV risk through the disclosure of HIV status before engaging in intimate relationships are important [The delivery of the intervention and recruitment of participants in this study were based on the internet-based social network strategy (SNS). SNS using an initial group of individuals as “seeds” or “egos” to recruit others within their social networks has been shown to effectively recruit a large number of high-risk MSM for HIV testing [ | PMC10337306 |
Methods | PMC10337306 | |||
Overview | This study analyzed the baseline data of MSM recruited in a cluster RCT in Guangzhou (Guangdong, China) from September 2019 to January 2022 [ | PMC10337306 |
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