Incidence and remission of post-surgical cystoid macular edema following cataract surgery in eyes with intraocular inflammation.

PURPOSE: To evaluate the incidence, remission and relapse of post-surgical cystoid macular edema (PCME) following cataract surgery in inflammatory eye disease. METHODS: A total of 1859 eyes that had no visually significant macular edema prior to cataract surgery while under tertiary uveitis management were included. Standardized retrospective chart review was used to gather clinical data. Univariable and multivariable logistic regression models with adjustment for inter-eye correlations were performed. RESULTS: PCME causing VA 20/50 or worse was reported in 286 eyes (15%) within 6 months of surgery. Adults age 18-64 years as compared to children (adjusted Odds ratio (aOR) 2.42, for ages 18-44 and aOR 1.93 for ages 45-64, overall p = 0.02); concurrent use of systemic immunosuppression (conventional aOR 1.53 and biologics aOR 2.68, overall p =0.0095); pre-operative VA 20/50 or worse (overall p <0.0001); cataract surgery performed before 2000 (overall p=0.03) and PMCE in fellow eye (aOR 3.04, p=0.0004) were associated with development of PCME within 6 months of cataract surgery. PCME resolution was seen in 81% of eyes at 12 months and 91% of eyes at 24 months. CME relapse was seen in 12% eyes at 12 months and 19% eyes at 24 months. CONCLUSIONS: PCME occurs frequently in uveitic eyes undergoing cataract surgery, however, most resolve within a year. CME recurrences likely are due to the underlying disease process and not relapses of PCME.

Posterior capsular opacification and YAG laser capsulotomy in uveitis patients following cataract surgery.

OBJECTIVE: To evaluate the incidence of visually significant posterior capsule opacification (PCO with visual acuity ≤20/50) and the incidence of Nd:YAG laser capsulotomy in the year following cataract surgery for uveitic eyes. METHOD: Patients were identified from the Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study using a standardized chart review process. RESULTS: Among 1,855 uveitic eyes of 1,370 patients who had undergone cataract surgery, visually significant PCO occurred in 297 eyes (16%), and YAG laser capsulotomy was done in 407 eyes (22%) within the first year following surgery. Higher odds of developing 20/50 visual acuity attributed to PCO were noted in children and young adults compared with adults older than 65 years of age (overall p = 0.03). Poorer preoperative visual acuity (overall p = 0.0069) and postoperative inflammation (odds ratio [OR] = 1.83; 95% CI, 1.37-2.45; p < 0.0001) were associated with PCO incidence. In multivariable analysis, risk factors for YAG laser capsulotomy were younger age groups compared with those older than 65 years of age at the time of surgery (adjusted OR [aOR] = 1.90-2.24; 95% CI, 1.90-2.24; overall p = 0.0007), female sex (aOR = 1.37; 95% CI, 1.03-1.82; p = 0.03), postoperative active inflammation (aOR = 165; 95% CI, 1.27-2.16; overall p < 0.0001), extracapsular cataract extraction compared with phacoemulsification (aOR = 1.70; 95% CI, 1.17-2.47; overall p < 0.0001), and insertion of an intraocular lens (aOR = 4.60; 95% CI, -2.29-9.25; p < 0.0001). Black race was associated with lower YAG laser capsulotomy incidence than Whites (aOR = 0.36; 95% CI, 0.24-0.52; overall p < 0.0001). CONCLUSIONS: Vision-reducing (≤20/50) PCO is common, occurring in about one sixth of uveitic eyes within 1 year of cataract surgery; a higher number (22%) of eyes underwent YAG laser capsulotomy within the first year. Age and postoperative inflammation following cataract surgery are the variables most associated with the incidence of visually significant PCO and YAG laser capsulotomy.

Accuracy and Reproducibility of Virtual Reality Perimetry in Children.

PURPOSE: To determine normal threshold values for the 24-2 program of the VisuALL-K (Olleyes, Inc), a portable static automated virtual reality perimeter that uses a video game-based testing modality on an updated version of the algorithm and to repeat the test to assess retest variability. METHODS: This prospective cohort study included 19 participants (aged 8 to 17 years) with healthy afferent systems. Participants performed two 24-2 automated perimetry tests on the virtual reality perimeter device. RESULTS: Mean age was 12.7 ± 2.5 years; 53% were boys and 47% were girls. Mean test location threshold was 30.5 ± 4.0 dB for test 1 and 31.3 ± 2.8 dB for test 2. Sensitivity decreased with eccentricity as expected (-0.17 dB per degree). Bland-Altman analysis showed a repeatability coefficient of ±5.1 dB for mean deviation, meaning that 95% of retest values were within ±5 dB of the threshold value for the first test. Higher thresholds for the first test regressed toward the mean values in the second test, indicating a learning effect. Intraclass correlation coefficient for mean deviation between test 1 and test 2 was 0.70 (0.55 to 0.80, P < .0001). Mean time to completion for the virtual reality perimeter was 5.1 ± 1.5 min/eye. CONCLUSIONS: The VisuALL-K virtual reality perimeter provided an assessment of the visual field in normal children aged 8 to 17 years. A shallow hill of vision was demonstrated. A notable learning effect was demonstrated, with repeatability difference wider than other published head-mounted display perimeters. [J Pediatr Ophthalmol Strabismus. 20XX:X(X):XX-XX.].

Long-term visual acuity outcomes following cataract surgery in eyes with ocular inflammatory disease.

PURPOSE: To evaluate the long-term visual acuity (VA) outcome of cataract surgery in inflammatory eye disease. SETTING: Tertiary care academic centres. DESIGN: Multicentre retrospective cohort study. METHODS: A total of 1741 patients with non-infectious inflammatory eye disease (2382 eyes) who underwent cataract surgery while under tertiary uveitis management were included. Standardised chart review was used to gather clinical data. Multivariable logistic regression models with adjustment for intereye correlations were performed to evaluate the prognostic factors for VA outcomes. Main outcome measure was VA after cataract surgery. RESULTS: Uveitic eyes independent of anatomical location showed improved VA from baseline (mean 20/200) to within 3 months (mean 20/63) of cataract surgery and maintained through at least 5 years of follow-up (mean 20/63). Eyes that achieved 20/40 or better VA at 1 year were more likely to have scleritis (OR=1.34, p<0.0001) or anterior uveitis (OR=2.2, p<0.0001), VA 20/50 to 20/80 (OR 4.76 as compared with worse than 20/200, p<0.0001) preoperatively, inactive uveitis (OR=1.49, p=0.03), have undergone phacoemulsification (OR=1.45 as compared with extracapsular cataract extraction, p=0.04) or have had intraocular lens placement (OR=2.13, p=0.01). Adults had better VA immediately after surgery, with only 39% (57/146) paediatric eyes at 20/40 or better at 1 year. CONCLUSIONS: Our results suggest that adult and paediatric eyes with uveitis typically have improved VA following cataract surgery and remain stable thereafter for at least 5 years.

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 2 with Recommendations for Surgical Termination of Pregnancy and Follow-up Care After Termination of Pregnancy.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, counselling of affected persons, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for an S2k-guideline, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations The guideline provides recommendations on the surgical termination of pregnancy and follow-up care after termination of pregnancy.

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 1 with Recommendations on Care Structures, Information and Advice on Decision-Making, Measures Before Abortion and Medical Abortion.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, the counselling of affected women, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for S2k-guidelines, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations A total of 61 recommendations are provided, covering care structures, provision of information and counselling to support decision-making, the measures to be taken before terminating the pregnancy, and medical termination of the pregnancy.

Comparison of Ophthalmologist and Large Language Model Chatbot Responses to Online Patient Eye Care Questions.

Importance: Large language models (LLMs) like ChatGPT appear capable of performing a variety of tasks, including answering patient eye care questions, but have not yet been evaluated in direct comparison with ophthalmologists. It remains unclear whether LLM-generated advice is accurate, appropriate, and safe for eye patients. Objective: To evaluate the quality of ophthalmology advice generated by an LLM chatbot in comparison with ophthalmologist-written advice. Design, Setting, and Participants: This cross-sectional study used deidentified data from an online medical forum, in which patient questions received responses written by American Academy of Ophthalmology (AAO)-affiliated ophthalmologists. A masked panel of 8 board-certified ophthalmologists were asked to distinguish between answers generated by the ChatGPT chatbot and human answers. Posts were dated between 2007 and 2016; data were accessed January 2023 and analysis was performed between March and May 2023. Main Outcomes and Measures: Identification of chatbot and human answers on a 4-point scale (likely or definitely artificial intelligence [AI] vs likely or definitely human) and evaluation of responses for presence of incorrect information, alignment with perceived consensus in the medical community, likelihood to cause harm, and extent of harm. Results: A total of 200 pairs of user questions and answers by AAO-affiliated ophthalmologists were evaluated. The mean (SD) accuracy for distinguishing between AI and human responses was 61.3% (9.7%). Of 800 evaluations of chatbot-written answers, 168 answers (21.0%) were marked as human-written, while 517 of 800 human-written answers (64.6%) were marked as AI-written. Compared with human answers, chatbot answers were more frequently rated as probably or definitely written by AI (prevalence ratio [PR], 1.72; 95% CI, 1.52-1.93). The likelihood of chatbot answers containing incorrect or inappropriate material was comparable with human answers (PR, 0.92; 95% CI, 0.77-1.10), and did not differ from human answers in terms of likelihood of harm (PR, 0.84; 95% CI, 0.67-1.07) nor extent of harm (PR, 0.99; 95% CI, 0.80-1.22). Conclusions and Relevance: In this cross-sectional study of human-written and AI-generated responses to 200 eye care questions from an online advice forum, a chatbot appeared capable of responding to long user-written eye health posts and largely generated appropriate responses that did not differ significantly from ophthalmologist-written responses in terms of incorrect information, likelihood of harm, extent of harm, or deviation from ophthalmologist community standards. Additional research is needed to assess patient attitudes toward LLM-augmented ophthalmologists vs fully autonomous AI content generation, to evaluate clarity and acceptability of LLM-generated answers from the patient perspective, to test the performance of LLMs in a greater variety of clinical contexts, and to determine an optimal manner of utilizing LLMs that is ethical and minimizes harm.

Evaluation of Outcomes of Acute Cataract Surgery-Related Endophthalmitis Using a Novel Management Algorithm Based on Presenting Risk Factors.

PURPOSE: Develop treatment algorithm for acute endophthalmitis (AE) following cataract surgery. METHODS: Retrospective single-center, non-randomized interventional study involving patients with AE divided into cohorts according to our novel scoring system, the Acute Cataract surgery-related Endophthalmitis Severity (ACES) score. Total score ≥3 points indicated need for urgent pars plana vitrectomy (PPV; within 24 hours), whereas <3 points indicated urgent PPV was unnecessary. Patients were retrospectively evaluated for visual outcomes based on whether their clinical course followed with or deviated from ACES score recommendations. Main outcome was best-corrected visual acuity (BCVA) at 6-month or longer after treatment. RESULTS: Total of 150 patients were analyzed. Patients whose clinical course followed the ACES score recommendation for immediate surgery had significantly (P < 0.01) better final BCVA (median = 0.18 logMAR, 20/30 Snellen) compared to those that deviated (median = 0.70 logMAR, 20/100 Snellen). For those where the ACES score deemed urgent PPV was unnecessary, no significant (P = 0.19) difference was observed between patients that followed with (median = 0.18 logMAR, 20/30 Snellen) and those that deviated from (median = 0.10 logMAR, 20/25 Snellen) recommendation. CONCLUSIONS: The ACES score may potentially provide critical and updated management guidance at presentation for when to recommend urgent PPV for patients suffering from post-cataract surgery AE.

Evaluation of Virtual Reality Perimetry and Standard Automated Perimetry in Normal Children.

Purpose: The Olleyes VisuALL-K is a pediatric videogame-based static threshold perimeter using a virtual reality headset. We determined normal threshold sensitivities for the 24-2 test locations using the virtual reality perimetry (VRP) and also tested patients on the Humphrey Field Analyzer (HFA). Patient satisfaction for the two instruments was compared. Methods: This exploratory study tested 50 normal pediatric participants aged 8 to 17 years on the HFA and VRP. The main outcome measure was threshold sensitivity at the 24-2 test locations for the two instruments. Results: The mean participant age was 13.0 ± 2.6 years; 50% were female. The threshold values for VRP are reported as measured on the device and after conversion to an HFA-equivalent scale. Age-adjusted thresholds showed a mean sensitivity of 31.8 ± 1.1 dB (46.1 ± dB HFA equivalent) diminution from the maximum light intensity in the VRP and 31.0 ± 1.5 dB diminution from the maximum light intensity in the HFA; interparticipant variability in mean threshold sensitivity was 2.7 ± 0.4 dB for the VRP and 2.7 ± 0.6 dB for the HFA. The HFA demonstrated decreased threshold sensitivity with increasing eccentricity, whereas the VRP threshold did not seem to vary with eccentricity. Mild age effects on threshold sensitivity were seen in the VRP and the HFA (R2 = 0.11, P < 0.001 and R2 = 0.05, P < 0.05, respectively). The mean time to completion for VRP and HFA was 7.6 ± 1.5 and 5.3 ± 0.9 min/eye, respectively (P < 0.0001). Patient satisfaction scores favored VRP (P < 0.01) despite the longer test duration. Conclusions: The Olleyes game-based VRP and HFA can be used to map out the peripheral vision in normal children. The VRP has a higher patient satisfaction when used in children than the HFA. The portability of the test allows it to be performed in a myriad of environments, lending a flexibility that can benefit this population. Translational Relevance: This virtual reality perimetry device provides an alternative to the Humphrey Field Analyzer for children.

Evaluation of Two-Dimensional (2D) versus Three-Dimensional (3D) Video Tutorials in Cataract Surgery for New Trainees.

Purpose Microscopic ophthalmic surgery requires an understanding of three-dimensional (3D) spaces within the eye. Recently, there has been an increase in 3D video training tools in health care. Studies have evaluated the efficacy of 3D tutorials in general surgery, but little has been published within ophthalmology. We present a randomized study evaluating differences in surgically naïve trainees after watching either a 2D or 3D phacoemulsification tutorial. Design This was a double-blind, randomized study. A group of third and fourth year medical students at our institution were randomized with stratified randomization based on prior surgical courses to control for differences in baseline surgical skill. The two study arms were watching 2D or 3D instructional videos on phacoemulsification (Richard Mackool). Methods Participants received a preliminary survey and participated in an hour-long microscopic surgery session. During the session, participants performed tasks evaluating baseline microscopic spatial awareness and surgical skill. The students were then instructed to watch either a 2D or 3D video on phacoemulsification based on their randomized study arm. During the postintervention session, participants performed the biplanar incision and capsulorhexis steps of cataract surgery discussed in the video on model eyes. Students were evaluated on speed and overall capsulorhexis quality. Results Thirty-one students qualified for the study and completed the microscopic surgery session. Students in both groups had similar baseline speed and quality of preintervention microscopic tasks ( p > 0.05 for all tasks). Postintervention, students randomized to the 3D video performed significantly faster than the 2D group for biplanar incision (11.1 ± 5.5 s vs. 20.7 ± 10.5 s, p = 0.001). There were no statistically significant differences found between the groups in capsulorhexis timing ( p = 0.12) or quality score ( p = 0.60). Conclusions 3D video surgical training tutorials may improve speed of certain steps of cataract surgery for surgically naïve ophthalmology trainees. Given the limited sample size of this study, further investigation of their effectiveness is warranted.

Depth-resolved extraction of optical attenuation for glaucoma assessment in clinical settings: a pilot study.

We assessed the ability of the optical attenuation coefficient (AC) to detect early-stage glaucoma with two AC estimation algorithms: retinal layer intensity ratio (LIR) and depth-resolved confocal (DRC). We also introduced new depth-dependent AC parameters for retinal nerve fiber layer assessment. Optical coherence tomography B-scans were collected from 44 eyes of age-similar participants with eye health ranging from healthy to severe glaucoma, including glaucoma suspect patients. Mean AC values estimated from the DRC method are comparable to ratio-extracted values (p > 0.5 for all study groups), and the depth-dependent ACDRC parameters enhance the utility of the AC for detection of early-stage glaucoma.

Eight-year follow-up of excimer laser trabeculostomy alone and combined with phacoemulsification in patients with open-angle glaucoma.

PURPOSE: To describe the 8-year results of excimer laser trabeculostomy (ELT) alone and ELT in conjunction with phacoemulsification (phaco). SETTING: University hospital. DESIGN: Retrospective review. METHODS: 308 nm excimer laser energy delivered through an intraocular fiber-optic probe created channels through the inner wall of Schlemm canal. 2 groups were studied: ELT alone and ELT + phaco. Inclusion criteria were adult patients with open-angle glaucoma or ocular hypertension on 1 or more intraocular pressure (IOP)-lowering medications and, in the ELT + phaco group, presence of visually significant cataract. Primary outcome measures were change of IOP from baseline and number of IOP-lowering medications. RESULTS: 164 eyes in 2 groups, ELT alone (n = 90) and ELT + phaco (n = 74), were followed up for 8 years. Baseline IOP was 22.17 ± 7.0 mm Hg and 21.9 ± 6.44 mm Hg in the ELT alone and the ELT + phaco groups, respectively. IOP in the ELT alone group decreased to 16.84 ± 5.2 mm Hg at 1 year (n = 69) and remained at 15.9 ± 3.5 (n = 19) at 8 years. IOP in the ELT + phaco group was 14.04 ± 4.1 mm Hg at 1 year (n = 63) and 13.7 ± 2.8 mm Hg at 8 years (n = 13). The number of IOP-lowering medications at baseline in the ELT alone group was 1.85 ± 0.8 and decreased to 1.19 ± 1.10 at 1 year and 1.4 ± 1.4 at 8 years. In the ELT + phaco group, it was 1.58 ± 0.8 at baseline and decreased to 0.97 ± 0.95 at 1 year and 1.85 ± 0.7 at 8 years. CONCLUSIONS: ELT demonstrated long-term IOP lowering and decrease in the number of IOP-lowering medications. Benefits of this laser-based implant-free microinvasive glaucoma surgery procedure included a high safety profile and long-term efficacy.

Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes.

PURPOSE: No approved therapies directly target retinal ganglion cells (RGCs) for neuroprotection or neuroenhancement in glaucoma. Recombinant human nerve growth factor (rhNGF) has been shown to promote RGC survival and function in animal models of optic neuropathy. Here we evaluate the safety, tolerability, and efficacy of short-term, high-dose rhNGF eye drops versus placebo in a cohort of glaucoma patients. DESIGN: This was a prospective, phase 1b, single-center, randomized, double-masked, vehicle-controlled, parallel-group study. METHODS: This study was designed to assess safety and tolerability as well as short-term neuroenhancement of structure and function (clinicaltrials.gov NCT02855450). A total of 60 open-angle glaucoma patients were randomized 40:20 to receive either 180 µg/mL rhNGF or vehicle control eye drops in both eyes, 3 times daily for 8 weeks, with a 24-week post-treatment follow-up. One eye was officially selected as the study eye, although both eyes were studied and dosed. Primary endpoints were safety, as assessed by adverse events, and tolerability, as assessed by patient-reported outcomes. Secondary outcome measures included best corrected visual acuity (BCVA), Humphrey visual field, electroretinograpy (ERG), and optical coherence tomography (OCT) of retinal nerve fiber layer (RNFL) thickness at baseline, after 8 weeks of treatment, and at 4 and 24 weeks after treatment (12 and 32 weeks total). RESULTS: Of the 60 randomized patients, 23 were female (38%) and the average age was 66.1 years. Through week 32, there were no treatment-related serious adverse events, including no unexpectedly severe progression of optic neuropathy, no adverse events affecting ocular function or pressure, and no drug-related systemic toxicity. Topical high-dose rhNGF was tolerated well, with a low level of symptom burden mainly eliciting periocular ache (in 52% of treated group and 5% of placebo group) and only 3 patients (7.5%) discontinuing treatment because of discomfort, of whom 1 patient (2.5%) prematurely withdrew from the study. There were no statistically significant differences in global indices of Humphrey visual field and no meaningful differences in total, quadrant, or clock-hour mean RNFL thickness between the groups, although both of these function and structure measures showed nonsignificant trends toward significance in favor of rhNGF. Real-world participant data was used to generate an estimate of cohort size needed to power subsequent studies. CONCLUSIONS: Use of rhNGF is safe and tolerable in a topical 180-µg/mL formulation. Although no statistically significant short-term neuroenhancement was detected in this trial, given the strong effects of NGF in preclinical models and the trends detected in this study, analysis for efficacy in a neuroprotection trial is warranted. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

Acute macular neuroretinopathy following Pfizer-BioNTech COVID-19 vaccination.

PURPOSE: To describe a case of acute macular neuroretinopathy (AMN) in a patient immediately following administration of the Pfizer-BioNTech COVID-19 vaccine. OBSERVATIONS: The patient complained of paracentral scotoma supported by paracentral visual field loss on multiple Humphrey visual fields that corresponded to outer retinal pathology on optical coherence tomography. The patient's symptoms resolved without treatment. CONCLUSIONS AND IMPORTANCE: We conclude that the clinical testing demonstrated findings consistent with AMN. AMN may be an exceedingly rare adverse ocular effect of a novel vaccine and likely only in the setting of multiple other risk factors. Despite this, we strongly recommend vaccination against COVID-19.

A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study.

Purpose: The purpose of this study was to describe a novel, virtual reality (VR)-based platform for evaluating visual fields. Methods: Three subjects were tested on the VisuALL VR headset. Data collected included test duration per eye, total fixation losses (FLs), total false positives (FPs), and total false negatives (FNs). Mean threshold values were collected from the superior temporal (ST), superior nasal (SN), inferior nasal (IN), inferior temporal (IT) quadrants, and from the central 12 degrees (central), 12 to 24 degrees (pericentral), and from all testing loci (global). Results: Six eyes of 3 subjects (2 men, 1 woman; mean age 30 years) were tested using the T-24 protocol (a Humphrey visual field [HVF] 24-2 equivalent). Mean test duration was 4.43 ± (SD) 0.11 minutes/eye. Mean threshold values ± SD for ST, SN, IN, IT, global, central, and pericentral were 31.1 ± 0.95 decibel (dB), 31.9 ± 0.3 dB, 32.0 ± 0.3 dB, 32.0 ± 1.1 dB, 31.9 ± 0.5 dB, 32.8 ± 0.5 dB, and 31.5 ± 0.5 dB, respectively. Conclusions: This work describes the technical aspects of the VisuALL. Participants were able to complete the test and generate threshold values at each of 50 locations in the central 24 degrees of visual field. This VR-based visual field test shows potential to become an alternative to analog, stationary standard automated perimetry tests. Translational Relevance: The VisuALL is an immersive, VR-based, automated perimeter that effectively addresses some of the limitations inherent to other popular perimetric devices. Potential advantages of the VisuALL are its adaptability, portability, and efficiency for patients. This device may be able to fill the gap present in at-home glaucoma monitoring and expand the reach of glaucoma management.

Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020.

IMPORTANCE: Diverse, representative enrollment in pivotal clinical trials is vital to sufficiently power subgroup analyses and ensure equity and validity of trial results. OBJECTIVE: To evaluate the racial/ethnic representation, trends, and disparities in clinical trials leading to US Food and Drug Administration (FDA) ophthalmology drug approvals from 2000 to 2020. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from participants in clinical trials of drugs for neovascular age-related macular degeneration (AMD), open-angle glaucoma (OAG), and expanded indications for diabetic retinopathy (DR) from January 1, 2000, to December 31, 2020. Trial data were sourced from FDA reviews, ClinicalTrials.gov, and relevant linked studies. National expected racial/ethnic proportions were sourced from public National Eye Institute prevalence data as well as published rates scaled using US Census Bureau data. MAIN OUTCOMES AND MEASURES: The primary outcome measures were the distribution of and change over time in the racial/ethnic proportion of participants in clinical trials leading to FDA approval of drugs for AMD, OAG, and DR. RESULTS: During the 20-year period, 31 clinical trials were identified for 13 medications with 18 410 participants. The distribution of trial participants was different from the expected trial distribution for most approvals with regard to race/ethnicity (12 drugs) and sex (10 drugs). Compared with the first decade (2000-2010), trials conducted in the second decade (2011-2020) showed increases in enrollment of Asian (odds ratio [OR], 2.30; 95% CI, 1.97-2.68; P < .001) and Hispanic or Latinx participants (OR, 1.74; 95% CI, 1.49-2.03; P < .001) for AMD, Asian participants (OR, 2.21; 95% CI, 1.46-3.42; P < .001) for DR, and Black (OR, 1.60; 95% CI, 1.43-1.78; P < .001) and Hispanic or Latinx participants (OR, 10.31; 95% CI, 8.05-13.35; P < .001) for OAG. There was a decrease in Black participants in DR trials (OR, 0.58; 95% CI, 0.42-0.79; P < .001). Based on these trends, the enrollment incidence ratio is expected to worsen by 2050, with overrepresentation of white participants vs underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for AMD (1.08 vs 0.04 vs 0.77), DR (1.83 vs 0.87 vs 0.59), and OAG (1.62 vs 0.90 vs 0.37). CONCLUSIONS AND RELEVANCE: In this cohort study, Black, Hispanic or Latinx, and other non-White participants were underrepresented in clinical trials leading to FDA ophthalmology drug approvals compared with the expected disease burden and racial/ethnic distribution in the US. Although there was meaningful improvement from 2000 to 2020, further efforts to increase minority enrollment in clinical trials seem to be warranted.