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Graefe's Archive For Clinical and... Mar 2022To evaluate the intraocular pressure (IOP)-reducing efficacy and safety of Rho-kinase inhibitor (RKI). (Meta-Analysis)
Meta-Analysis
PURPOSE
To evaluate the intraocular pressure (IOP)-reducing efficacy and safety of Rho-kinase inhibitor (RKI).
METHODS
Published studies in PubMed and EMBASE were searched on March 20, 2021. Study selection and data extraction were performed according to PRISMA. Meta-analysis of the IOP-lowering effect was performed with the bivariate random-effects model, with studies categorized into 2 classes: RKI versus placebo and RKI versus another medication. The main outcome was the difference in IOP reduction between RKI and non-RKI groups. Subgroup analysis of adjunctive RKI efficacy and additional review of its major ocular adverse events (AE) were also performed.
RESULTS
Ten (2.6%) out of 391 studies were retrieved. In the RKI versus placebo class, RKI showed greater IOP reduction after 4-8 weeks (mean difference = - 1.69 mmHg [- 2.22, - 1.16], P < 0.001). In the RKI versus another medication class, IOP reduction by RKI was noninferior to timolol 0.5% twice-daily after 4-8 weeks (mean difference = 0.39 mmHg [0.01, 0.76], P = 0.043) and 12 weeks (mean difference = 0.48 mmHg [0.11, 0.85]; P = 0.011). In the subgroup analysis, the mean difference in IOP reduction by adjunctive RKI and placebo was - 1.42 mmHg (P < 0.001). The most common ocular AE of RKI was conjunctival hyperemia (19-65%), followed by conjunctival hemorrhage (6-20%) and cornea verticillata (13-26%).
CONCLUSIONS
With a treatment duration of 1-3 months, RKI showed effective IOP reduction noninferior to timolol as monotherapy and as adjunctive therapy. Our results suggested RKI be a reliable IOP control medication; however, its higher incidence of some ocular complications should be attended to.
Topics: Humans; Antihypertensive Agents; Double-Blind Method; Glaucoma; Glaucoma, Open-Angle; Intraocular Pressure; Ocular Hypertension; Ophthalmic Solutions; Randomized Controlled Trials as Topic; rho-Associated Kinases; Timolol; Treatment Outcome
PubMed: 34491427
DOI: 10.1007/s00417-021-05379-7 -
Frontiers in Endocrinology 2022This meta-analysis was conducted to explore the association between sodium-glucose cotransporter 2 inhibitors (SGLT-2is) and ocular diseases in type 2 diabetes mellitus... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This meta-analysis was conducted to explore the association between sodium-glucose cotransporter 2 inhibitors (SGLT-2is) and ocular diseases in type 2 diabetes mellitus (T2DM) patients.
METHODS
PubMed, Cochrane Central Registry of Controlled Trials, Web of Science and Springer were searched for articles on randomized controlled trials (RCTs) involving T2DM patients treated with SGLT-2i versus placebo or other hypoglycemic agents published prior to August 2021. The primary outcome of this meta-analysis was incidence of ocular diseases, which was assessed using risk ratios (RR) and 95% confidence intervals (CI). We reviewed 47 papers and compared the effect of SGLT-2i with the effect of the control groups (placebo and other hypoglycemic drugs) on the incidence of ocular diseases.
RESULTS
Compared with controls, overall SGLT-2i use in T2DM patients was not associated with incidences of cataract, glaucoma, retinal disease and vitreous disease. Ertugliflozin (RR=0.47, P=0.01) reduced the risk for retinal disease, while empagliflozin (RR=0.44, P=0.05) reduced the risk for diabetic retinopathy (DR) compared with controls. SGLT-2i (RR=0.50, P=0.02), perhaps empagliflozin (RR=0.47, P=0.06), reduced the risk of retinal disease compared with active hypoglycemic agents. Canagliflozin (RR=4.50, P=0.03) increased the risk for vitreous disease compared with placebo.
CONCLUSIONS
There was no significant correlation between overall SGLT-2i and ocular diseases (cataract, glaucoma, retinal disease, vitreous disease, corneal disease, conjunctival disease, uveal disease, eye haemorrhage and vision problems) in T2DM patients. Ertugliflozin and empagliflozin may protect against ocular diseases, but canagliflozin may promote ocular diseases.
Topics: Canagliflozin; Cataract; Diabetes Mellitus, Type 2; Glaucoma; Humans; Hypoglycemic Agents; Randomized Controlled Trials as Topic; Retinal Diseases; Sodium-Glucose Transporter 2 Inhibitors
PubMed: 35692406
DOI: 10.3389/fendo.2022.907340 -
JAMA Network Open May 2021The disease burden for primary open-angle glaucoma (POAG) is highest among racial/ethnic minority groups, particularly Black individuals. The prevalence of POAG... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The disease burden for primary open-angle glaucoma (POAG) is highest among racial/ethnic minority groups, particularly Black individuals. The prevalence of POAG worldwide is projected to increase from 52.7 million in 2020 to 79.8 million in 2040, a 51.4% increase attributed mainly to Asian and African individuals. Given this increase, key stakeholders need to pay particular attention to creating a diverse study population in POAG clinical trials.
OBJECTIVE
To assess the prevalence of racial/ethnic minorities in POAG clinical research trials compared with White individuals.
DATA SOURCES
This meta-analysis consisted of publicly available POAG clinical trials using ClinicalTrials.gov, PubMed, and Drugs@FDA from 1994 to 2019.
STUDY SELECTION
Randomized clinical trials that reported on interventions for POAG and included demographic subgroups including sex and race/ethnicity.
DATA EXTRACTION AND SYNTHESIS
Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 2 independent reviewers extracted study-level data for a random-effects meta-analysis. A third person served as the tiebreaker on study selection. Microsoft Excel 2016 (Microsoft Corporation) and SAS, version 9.4 (SAS Institute) were used for data collection and analyses.
MAIN OUTCOMES AND MEASURES
The primary outcomes were the prevalence of each demographic subgroup (White, Black, Hispanic/Latino, other race/ethnicity groups, and female or male) in each trial according to the trial start year, study region, and study sponsor. Participation rates are expressed as percentages.
RESULTS
A total of 105 clinical trials were included in the meta-analysis, including 33 428 POAG clinical trial participants (18 404 women [55.1%]). Overall, 70.7% were White patients, 16.8% were Black patients, 3.4% were Hispanic/Latino patients, and 9.1% were individuals of other races/ethnicities, including Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, and unreported as defined by the US Census. The mean (SD) numbers of participants by race/ethnicity were 236.5 (208.2) for White, 58.4 (70.0) for Black, 29.9 (71.1) for Hispanic/Latino, and 31.1 (94.3) for other race/ethnicity. According to the test for heterogeneity using the Cochrane Risk of Bias tool, the I2 statistic was 98%, indicating high heterogeneity of outcomes in the included trials. A multiple linear regression analysis was performed to assess any trend and significance between participation by Black individuals and the year the study started, the region in which the study took place, and the study sponsor. There was no significant increase of Black participant enrollment from 1994 to 2019 (r2 = 0.11; P = .17) and no significant association between Black participant enrollment and clinical trial region (r2 = 0.16; P = .50), but there was a significant association between Black participant enrollment and study sponsor (r2 = 0.94; P = .03).
CONCLUSIONS AND RELEVANCE
This meta-analysis found that compared with White individuals, individuals from racial/ethnic minority groups had a very low participation rate in POAG clinical trials despite having a higher prevalence among the disease population. Despite measures to increase clinical trial diversity, there has not been a significant increase in clinical trial participation among Black individuals, the group most affected by this disease; this disparity in POAG clinical trial representation can raise questions about the true safety and efficacy of approved medical interventions for this disease and should prompt further research on how to increase POAG clinical trial diversity.
Topics: Clinical Trials as Topic; Ethnic and Racial Minorities; Glaucoma, Open-Angle; Healthcare Disparities; Humans; Patient Selection; United States
PubMed: 34003274
DOI: 10.1001/jamanetworkopen.2021.8348 -
Eye (London, England) Nov 2023We conducted this research to determine the prevalence rate and presentation patterns with microcystic macular oedema (MMO) in glaucoma patients. The protocol was... (Meta-Analysis)
Meta-Analysis Review
We conducted this research to determine the prevalence rate and presentation patterns with microcystic macular oedema (MMO) in glaucoma patients. The protocol was pre-registered on PROSPERO ( CRD42022316367 ). PubMed, Scopus, Web of Science, EMBASE, ProQuest, EBSCOHost, CENTRAL, clinicaltrials.gov, and Google Scholar were searched for articles reporting MMO in glaucoma patients. The primary outcome was the prevalence of MMO, while secondary outcomes included the comparison between MMO and non-MMO in terms of patients' characteristics (age, gender), glaucoma stage, and ocular parameters (axial length (AL), intraocular pressure, mean deviation, spherical equivalent). Data are reported as mean difference (MD) or log odds ratio (logOR) along with their corresponding 95% confidence intervals (CI) for continuous and dichotomous outcomes, respectively. The quality of included studies was assessed using the NIH tool, and the certainty of evidence was assessed using GRADE framework. Ten studies (2128 eyes) were included, revealing an overall prevalence rate of MMO of 8% (95%CI: 5-12%). When compared to non-MMO group, MMO was associated with lower age (MD = -5.91; 95%CI: -6.02: -5.20), greater risk of advanced glaucoma stage (LogOR=1.41; 95%CI: 0.72: 2.09), and lower mean deviation of the visual field (MD = -5.00; 95%CI: -7.01: -2.99). No significant difference was noted between both groups in terms of gender, axial length, or spherical equivalent. Three studies had good quality while seven had poor quality. MMO is a prevalent observation in glaucoma patients and is associated with patients' age and stage of the disease. However, the certainty of evidence remains very low.
Topics: Humans; Macular Edema; Prevalence; Glaucoma; Intraocular Pressure
PubMed: 37072471
DOI: 10.1038/s41433-023-02524-w -
Progress in Brain Research 2020glaucoma is a remarkable social issue being the leading cause of irreversible blindness worldwide. It is a progressive neuropathy characterized by the death of the...
BACKGROUND
glaucoma is a remarkable social issue being the leading cause of irreversible blindness worldwide. It is a progressive neuropathy characterized by the death of the retinal ganglion cells, of which the most important risk factor is represented by the increase of intraocular pressure (IOP). The role of nutraceutical supplementations with anti-oxidant activity has been extensively tested in preclinical models of glaucoma. The clinical efficacy of nutraceuticals in glaucoma is still controversial.
OBJECTIVES
the aim of this systematic review is to assess the efficacy of nutraceuticals with anti-oxidant activity in glaucoma through the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) rigorous criteria.
DATA SOURCES
the literature search has been performed on the electronic databases currently recognized of most relevance for medical scientific literature, i.e. PubMed, MEDLINE, The Cochrane Central Register of Controlled Trials (CENTRAL) with access to EMBASE, ClinicalTrials.gov and Scopus. The date of last search is April 8th, 2020. Study eligibility criteria, participants, and interventions: prospective randomized clinical trials assessing the effects of nutraceuticals and anti-oxidants on IOP and/or visual field in patients with glaucoma. The eligible papers must be published in English and available in full text.
STUDY APPRAISAL AND SYNTHESIS METHODS
the evaluation of the eligibility of the studies has been carried out independently by two authors. The selection process has followed the PRISMA flow diagram, assessing the quality of the body of evidence and the risk of bias.
RESULTS
the search of literature has retrieved 1615 papers and 2 clinical trials with results, among which only 6 are eligible for inclusion in the present systematic review to address the preset participants, interventions, comparisons, outcomes and study design (PICOS) "are the nutraceuticals effective in glaucoma?". In 5 out of 6 studies the nutraceutical supplementation is effective in providing additional decrease of IOP to current usual therapy, without the occurrence of side effects. However, all the studies present high heterogeneity and some concerns in terms of risk of bias, apart from one trial for which the risk of bias is low.
CONCLUSIONS
the evidence of effectiveness of nutraceutical formulations is still uncertain and inconclusive. Therefore, large double-blind randomized clinical trials with adequate design, methodology and statistical power are needed to support the use of nutraceuticals in glaucoma.
Topics: Dietary Supplements; Glaucoma; Humans; Intraocular Pressure; Prospective Studies; Randomized Controlled Trials as Topic; Visual Fields
PubMed: 32988469
DOI: 10.1016/bs.pbr.2020.07.014 -
American Journal of Ophthalmology Mar 2024Many studies have examined the ocular pulse amplitude (OPA) to better understand its physiology and clinical relevance, but the papers are scattered, not consistently... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Many studies have examined the ocular pulse amplitude (OPA) to better understand its physiology and clinical relevance, but the papers are scattered, not consistently indexed, and sometimes difficult to locate. We aimed to identify and summarize the relevant published evidence on OPA and, in a meta-analysis, outline specific differences of this parameter between healthy individual, primary open-angle glaucoma, normal-tension glaucoma, ocular hypertension, and cataract patients.
DESIGN
Systematic review and meta-analysis.
METHODS
A thorough literature search and data extraction were conducted by 2 reviewers independently. Reports on OPA measured by the dynamic contour tonometry in conjunction with different ocular and systemic diseases or potential influencing factors were included.
RESULTS
Of the 527 initially found reports, 97 met the inclusion criteria assessing 31 clinical conditions. A meta-analysis based on 6850 eyes and 106 study arms (68.8%) revealed differences in mean OPA values in millimeters of mercury between various entities. Among healthy eyes, the OPA was 2.58 mm Hg (95% CI: 2.45-2.71), whereas OPA values were higher in glaucoma (unspecified glaucoma 2.73 mm Hg, 95% CI: 2.38-3.08; normal-tension glaucoma 2.66 mm Hg, 95% CI: 2.36-2.97; and primary open-angle glaucoma 2.92 mm Hg, 95% CI: 2.75-3.08). Although ocular hypertension showed the highest OPA values (3.53 mm Hg, 95% CI: 3.05-4.01), the lowest values were found in cataract eyes (2.26 mm Hg, 95% CI: 1.57-2.94).
CONCLUSION
We found different OPA values characteristic of different clinical entities, with above-normal values in glaucoma and ocular hypertension and lower values in cataract patients. Our work is intended for clinicians and researchers who want to get a quick overview of the available evidence or who need statistical data on OPA distributions in individual diseases.
Topics: Humans; Intraocular Pressure; Glaucoma, Open-Angle; Healthy Volunteers; Blood Pressure; Glaucoma; Ocular Hypertension; Tonometry, Ocular; Low Tension Glaucoma; Cataract
PubMed: 37898282
DOI: 10.1016/j.ajo.2023.10.014 -
Ophthalmic Research 2023Prostaglandin analogs (PGAs) are first-line antiglaucoma agents that appear to either decrease or increase central cornea thickness (CCT), creating controversy regarding... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Prostaglandin analogs (PGAs) are first-line antiglaucoma agents that appear to either decrease or increase central cornea thickness (CCT), creating controversy regarding the benefits of PGAs in treating CCT.
PURPOSE
We performed the first meta-analysis of observational studies to evaluate the effects of PGAs on CCT in patients with glaucoma or ocular hypertension (OHT).
METHODS
This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. A literature search was performed of the PubMed, Embase, Cochrane Library, System for Information on Grey Literature in Europe (Open Grey), and ClinicalTrials.gov databases and the references of retrieved studies. Only observational studies were included in the meta-analysis. The final CCT of patients and 95% confidence interval (CI) of each study were extracted. Study quality was assessed using the Newcastle-Ottawa Scale (NOS) and the Agency for Healthcare Research and Quality (AHRQ). A fixed-effects model was used to calculate the weighted mean difference (WMD) and 95% CI. Subgroup analyses based on several stratified factors such as public bias (Begg's test) and sensitivity analyses were performed.
RESULTS
Five cohort, 5 case-control, and three cross-sectional studies including 2,722 subjects were included. The pooled effect of all thirteen studies showed that PGAs reduced the CCT of patients with glaucoma or OHT slightly but significantly (WMD = -9.37; 95% CI [-12.18, -6.57]; p = 0.00; I2 = 45.5%). Significant effects were also observed in all three study designs: cohort (WMD = -5.17; 95% CI [-9.52, -0.82]), case-control (WMD = -15.31; 95% CI [-22.66, -7.97]), and cross-sectional (WMD = -8.65; 95% CI [-17.30, -0.01]). In addition, subgroup analysis of exposure time showed the effect of PGAs to be more obvious in the first (WMD = -5.81; 95% CI [-9.49, -2.14]) and second (WMD = -13.73; 95% CI [-20.19, -7.28]) years.
CONCLUSIONS
The pooled effects of previously reported studies suggest that PGA use can reduce the CCT of patients with glaucoma or OHT slightly but significantly, with this effect more pronounced in the first 2 years. These findings suggest that clinicians must closely monitor changes in CCT in the first 2 years of PGA use to identify cases of intraocular pressure misestimation and the efficacy of PGAs.
Topics: Humans; Cross-Sectional Studies; Glaucoma, Open-Angle; Cornea; Glaucoma; Ocular Hypertension; Intraocular Pressure; Tonometry, Ocular; Prostaglandins, Synthetic
PubMed: 36455536
DOI: 10.1159/000528461 -
Survey of Ophthalmology 2019We have systematically extracted all available heritability (h) estimates of glaucoma and related endophenotypes from the literature and summarized the evidence by... (Meta-Analysis)
Meta-Analysis
We have systematically extracted all available heritability (h) estimates of glaucoma and related endophenotypes from the literature and summarized the evidence by meta-analysis. Glaucoma endophenotypes were classified into 10 clusters: intraocular pressure, anterior chamber size, central corneal thickness, cup-to-disc ratio, disc size, cup size, corneal hysteresis, retinal nerve fiber layer thickness, cup shape, and peripapillary atrophy. Random-effects meta-analyses were performed for each cluster. For clusters with n ≥ 10 h estimates, we also performed subgroup and meta-regression analyses. The literature search yielded 53 studies. The h of primary open-angle glaucoma ranged from 0.17 to 0.81, and was 0.65 for primary angle-closure glaucoma in a single study. The pooled endophenotype h estimates were intraocular pressure, 0.43 (0.38-0.48); anterior chamber size, 0.67 (0.60-0.74); central corneal thickness, 0.81 (0.73-0.87); cup-to-disc ratio, 0.56 (0.44-0.68); disc size, 0.61 (0.37-0.81); cup size, 0.58 (0.35-0.78); corneal hysteresis, 0.40 (0.29-0.51); retinal nerve fiber layer thickness, 0.73 (0.42-0.91); cup shape, 0.62 (0.22-0.90); and peripapillary atrophy, 0.73 (0.70-0.75). We identified mean age, ethnicity, and study design as major sources of heterogeneity. Our results confirm the strong influence of genetic factors on glaucoma and its endophenotypes. These pooled h estimates provide the most accurate assessment to date of the total genetic variation that can ultimately be explained by gene-finding studies.
Topics: Genetic Predisposition to Disease; Glaucoma; Humans; Phenotype; Quantitative Trait, Heritable
PubMed: 31229521
DOI: 10.1016/j.survophthal.2019.06.002 -
Investigative Ophthalmology & Visual... Aug 2022To compare the burden of age-related eye diseases among adults exposed to higher versus lower levels of ambient air pollutants. (Meta-Analysis)
Meta-Analysis
PURPOSE
To compare the burden of age-related eye diseases among adults exposed to higher versus lower levels of ambient air pollutants.
METHODS
MEDLINE, EMBASE, and Scopus were searched for relevant articles until September 30, 2021. Inclusion criteria included studies of adults, aged 40+ years, that provided measures of association between the air pollutants (nitrogen dioxide, carbon monoxide [CO], sulfur dioxide, ozone [O3], particulate matter [PM] less than 2.5 µm in diameter [PM2.5], and PM less than 10 µm in diameter [PM10]) and the age-related eye disease outcomes of glaucoma, age-related macular degeneration (AMD), or cataract. Pooled odds ratio (OR) estimates and 95% confidence intervals (CIs) were calculated using a random-effects meta-analysis model. PROSPERO registration ID: CRD42021250078.
RESULTS
A total of eight studies were included in the review. Consistent evidence for an association was found between PM2.5 and glaucoma, with four of four studies reporting a positive association. The pooled OR for each 10-µg/m3 increase of PM2.5 on glaucoma was 1.18 (95% CI, 0.95-1.47). Consistent evidence was also found for O3 and cataract, with three of three studies reporting an inverse association. Two of two studies reported a null association between PM2.5 and cataract, while one of one studies reported a positive association between PM10 and cataract. One of one studies reported a positive relationship between CO and AMD. Other relationships were less consistent between studies.
CONCLUSIONS
Current evidence suggests there may be an association between some air pollutants and cataract, AMD, and glaucoma.
Topics: Adult; Air Pollutants; Air Pollution; Cataract; Environmental Exposure; Glaucoma; Humans; Ozone; Particulate Matter
PubMed: 35960515
DOI: 10.1167/iovs.63.9.17 -
Journal of Glaucoma Jun 2022To systematically summarize the current literature on home-based perimeters for glaucoma.
PURPOSE
To systematically summarize the current literature on home-based perimeters for glaucoma.
METHODS
A systematic review was conducted in accordance with the PRISMA-DTA checklist. Studies reporting portable perimeters designed for home use were retrieved from electronic databases and handsearching of reference lists of relevant publications. Studies reporting diagnostic accuracy data were evaluated with the QUADAS-2 tool and using standard automated perimetry as the reference standard. Other aspects of the technology such as detection of disease progression and patient acceptability were also included. Data were reported in a narrative and tabular format.
RESULTS
Of 18 included studies, 10 evaluated tablet-based perimeters, 4 evaluated web-based perimeters, and 4 evaluated head-mounted displays. Most studies used a clinic or laboratory setting. All studies reporting diagnostic accuracy data had high risk of bias in at least one domain. Across studies, sensitivity ranged from 54% in detecting mild to 91% in detecting moderate/severe glaucoma patients from controls, while specificity was between 50% and 100% for any form of glaucoma. The reported acceptability was high but had high risk of bias.
CONCLUSION
Several promising technologies designed for home-based perimetry have been reported. Current studies used a controlled setting in highly selected populations. There is uncertainty on the performance and value of home-based perimetry for glaucoma. Additional efforts are required to elucidate the ability of the home-based perimeters to detect glaucoma and disease progression in real life situations.
Topics: Disease Progression; Glaucoma; Humans; Intraocular Pressure; Sensitivity and Specificity; Visual Field Tests
PubMed: 35394454
DOI: 10.1097/IJG.0000000000002022