SALT Trial: Steroids after Laser Trabeculoplasty: Impact of Short-Term Anti-inflammatory Treatment on Selective Laser Trabeculoplasty Efficacy.

PURPOSE: This study examined whether short-term use of topical nonsteroidal anti-inflammatory drug (NSAID) or steroid therapy affected the efficacy of selective laser trabeculoplasty (SLT). DESIGN: Double-masked, randomized, placebo-controlled, dual-center, multisurgeon trial. PARTICIPANTS: Patients older than 18 years with intraocular pressure (IOP) of more than 18 mmHg for whom the clinician decided SLT was the appropriately indicated therapy were randomized to 1 of 3 groups in a ratio of 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears. METHODS: After SLT, patients randomized into each group were instructed to use an unmarked drop 4 times daily starting the day of SLT and continuing for 4 additional days. The Kruskal-Wallis test and Wilcoxon rank-sum test were used for continuous variables when comparing 2 or 3 treatment groups, respectively. The Fisher exact test was used for categorical variables. MAIN OUTCOME MEASURES: The primary outcome of this study was IOP at 12 weeks. Secondary outcome measures included IOP at 1 and 6 weeks, patient-reported pain, and detectable anterior chamber inflammation. RESULTS: Ninety-six eyes of 85 patients fit inclusion criteria and were enrolled between the 2 sites. The NSAID, steroid, and placebo groups were similar in baseline demographics and baseline IOP (mean, 23.3±3.9 mmHg; P = 0.57). There was no statistically significant difference in IOP decrease among groups at week 6. Both the NSAID and steroid groups showed a statistically significantly greater decrease in IOP at week 12 compared with the placebo group (mean, -6.2±3.1 mmHg, -5.2±2.7 mmHg, and -3±4.3 mmHg, respectively; P = 0.02 [analysis of variance] and P = 0.002 [t test] for NSAID vs. placebo groups; P = 0.02 for steroid vs. placebo groups). CONCLUSIONS: Significantly better IOP reduction at 12 weeks was measured in eyes treated with steroid or NSAID drops after SLT. Short-term postoperative use of NSAID or steroid drops may improve IOP reduction after SLT. Longer-term follow-up studies are indicated.

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. 2024:61(4):262-266.].

Open-angle glaucoma and Fuchs dystrophy.

A 62-year-old woman with a history of moderate myopia, long-standing open-angle glaucoma (OAG), and Fuchs dystrophy in both eyes was referred for consultative care. She had prior trabeculectomy in 1984 and 1992 in the left and right eyes, respectively. She is 3 months post-Descemet-stripping endothelial keratoplasty (DSEK) in the left eye, now referred with uncontrolled intraocular pressure (IOP) despite maximum tolerated medical therapy. Current medical therapy for IOP consists of acetazolamide 250 mg by mouth 2 times a day, brimonidine 2 times a day in the left eye, dorzolamide 2 times a day in the left eye, and timolol 2 times a day in the left eye. The patient has a history of presumed steroid response; however, her corneal surgeon has requested that the steroid be continued for the next several months because of the recent DSEK. The IOP in the left eye has ranged from the mid-20s to mid-30s since DSEK. The right eye has consistently had pressure in the low teens and below for many years without topical antihypertensive medications. Examination revealed stable visual acuity at 20/30 and 20/40 in the right and left eyes, respectively, IOP was 12 mm Hg in the right eye and 25 mm Hg in the left eye by Goldman applanation, irregular but reactive pupils without afferent defect, and full confrontational visual fields. Slitlamp examination showed superior low avascular bleb, moderate-to-severe guttae, and posterior chamber IOL in the right eye. The left eye showed superior low diffuse bleb, clear DSEK graft, quiet chamber, superonasal iridectomy, and posterior chamber IOL with an open posterior capsule. The conjunctiva was moderately scarred but a repeat trabeculectomy or Xen Gel stent (Abbvie) appeared possible. The angles were wide open in each eye. Fundus examination was normal aside from myopic, anomalous-appearing nerves with an approximate cup-to-disc ratio of 0.90 in both eyes. Humphrey visual field showed nonspecific changes on the right and moderate nasal defect on the left eye, stable to previous examinations dating back to 2018 (Figure 1JOURNAL/jcrs/04.03/02158034-202407000-00018/figure1/v/2024-07-10T174240Z/r/image-tiff and Figure 2JOURNAL/jcrs/04.03/02158034-202407000-00018/figure2/v/2024-07-10T174240Z/r/image-tiff). Optical coherence tomography (OCT) of the retinal nerve fiber layer (RNFL) revealed moderated thinning in both eyes that was also stable to prior examinations (Figure 3JOURNAL/jcrs/04.03/02158034-202407000-00018/figure3/v/2024-07-10T174240Z/r/image-tiff). Her axial length measured 25.23 and 26.34 mm in the right and left eyes, respectively. Central corneal thickness was 553 µm in the right eye and 563 µm in the left eye before her DSEK procedure. What would be your approach to management of this patient's left eye, addressing the following: Rationale for your procedure of choice? Would you over-rule the corneal surgeon and stop the steroid in an attempt to obviate the need for glaucoma surgery? Does the age of onset of glaucoma affect your surgical decision making? Note that patient age at the time of trabeculectomy was 22 years. Are some procedures better suited for patients after DSEK surgery?

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.

Association of OCT angle recess width with IOP response after intravitreal triamcinolone injection.

PURPOSE: A circumferential pretrabecular anatomical structure, the angle recess (AR), can be imaged with anterior segment ocular coherence tomography. AR's utility to predict ocular hypertension after intravitreal triamcinolone injection was assessed. METHODS: All intravitreal triamcinolone injection recipients from 2002 to 2005 with high-resolution anterior segment ocular coherence tomography images had AR width (between the anteriormost prominence of the iris root and posterior cornea) measured by masked physicians using the caliper function of Stratus ocular coherence tomography. Intraocular pressures (IOPs) from 1 month before to 6 months after the injection were compiled for IOP rise (Δ) and maximal IOP (max), categorized as "minimal" (IOPmax < 21 mmHg and/or IOPΔ ≤ 5 mmHg), "moderate" (IOPmax 21-29 mmHg and/or IOPΔ 6-14 mmHg), or "severe" (IOPmax ≥ 30 mmHg and/or IOPΔ ≥ 15 mmHg). Linear regression and analyses of variance were applied. RESULTS: Twenty-six eyes satisfied the entry criteria, with 11 (42%) eyes demonstrating minimal, 11 (42%) moderate, and 4 (15%) severe IOP responses. The corresponding (mean ± SEM) AR widths were: 326 ± 31.5 µm, 281 ± 22.0 µm, and 138 ± 20.3 µm, respectively. Highly significant AR width differences existed between moderate and severe responders and between minimal and severe responders (both P < 0.004); 5 of 6 patients with IOP ≥ 29 mmHg had AR < 200 µm. CONCLUSION: These findings indicate that a potentially clinically useful relationship exists between AR width and IOP elevation accompanying intravitreal triamcinolone injection. Anterior segment screening could become a beneficial extension of ocular coherence tomography for retinal practices.

Retinal nerve fiber layer thickness using spectral-domain optical coherence tomography in patients with no light perception secondary to optic atrophy.

BACKGROUND: Optical coherence tomography (OCT) provides useful structural information that can augment functional data. Newer spectral-domain technology provides faster and higher resolution images than time-domain machines. Although each measures the same structures, the values systematically differ. We evaluated eyes with longstanding no light perception (NLP) visual acuity secondary to optic atrophy using spectral-domain OCT to determine minimum retinal nerve fiber layer (RNFL) thickness. METHODS: The authors conducted a retrospective, cross-sectional chart review study to identify patients with NLP acuity for 8 months or more and having a good quality Spectralis OCT (Heidelberg Engineering, Heidelberg, Germany) to measure the RNFL thickness. An unpaired t test compared the eyes with a previously published data set measured with time-domain OCT. RESULTS: Eleven eyes from 10 patients were examined with the Spectralis OCT. The mean duration of documented NLP acuity was 3.72 ± 1.20 years. The mean RNFL thickness was 34.18 ± 2.66 µm (95% confidence interval, 28.26-40.11 µm). Mean RNFL thickness was significantly thinner on this spectral-domain OCT than previously published values on time-domain OCT (34.18 vs 45.42 µm, P = 0.004). CONCLUSION: Using the Spectralis OCT, mean RNFL thickness for NLP eyes due to optic atrophy is 28-40 µm. This provides clinicians useful information when considering how aggressively to manage patients with optic nerve disease.

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.

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.

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.

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.

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.

New Strategies for Automated Perimetry: Historical Perspective and Future Innovations.

How to cite this article: Groth SL. New Strategies for Automated Perimetry: Historical Perspective and Future Innovations. J Curr Glaucoma Pract 2021;15(3):103-105.

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.

Bilateral Acute Angle Closure in a Pediatric Patient Taking Lisdexamfetamine Dimesylate (Vyvanse).

Attention-deficit/hyperactivity disorder is commonly treated with amphetamines as first line therapy. Rare case reports have shown amphetamines are associated with open angle glaucoma. We report a rare case of a 14-year-old male who presented with bilateral acute angle closure presumed to be related to his use of lisdexamfetamine dimesylate (Vyvanse). The patient's medication was discontinued which resulted in complete resolution of angle closure.

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.

Mask-induced Artifact Impacts Intraocular Pressure Measurement Using Goldmann Applanation Tonometry.

PURPOSE: The coronavirus (COVID-19) pandemic has impacted ophthalmology practices significantly. American Academy of Ophthalmology and Center for Disease Control guidelines suggest mandatory masking of patients and physicians during outpatient visits. We have recently become aware of a mask-induced phenomenon, whereby the intraocular pressure (IOP) as measured by Goldmann applanation tonometry (GAT) is artificially elevated due to mechanical interference from the mask. CLINICAL PRESENTATION: A 37-year-old male with a history of primary open-angle glaucoma on triple therapy presented for a routine visit. CLINICAL FINDINGS: When measuring IOP by GAT the right eye measured 16 mm Hg, but the left eye measured 20 mm Hg. The patient's mask was noted to be touching the base of the sensor rod on the tonometer. This patient's IOP was falsely elevated due to the lateral edge of his mask touching the base of the applanation tonometer, changing the relationship between the bi-prism tip and the weighted balance below, and eliminating the weighted balance from the pressure measuring mechanism. The patient's mask was adjusted to ensure there was no touch and repeat measurement showed an IOP of 16 mm Hg in the left eye. CONCLUSION: Recognizing mask-induced alteration in IOP is essential as it could lead to unnecessary escalation of treatment. We recommend flattening the area of mask protrusion during applanation and ensuring that the sensor arm remains clear of the mask while the tonometer tip approaches the cornea, especially at the moment the mires become visible during corneal contact.