CHARACTERISTICS OF PARTICIPANTS IN DIABETIC RETINOPATHY CLINICAL RESEARCH CLINICAL TRIALS WHO WERE LOST TO FOLLOW-UP.

PURPOSE: Our study describes the racial/ethnic composition and the broad health status/severity of disease of the cohorts of Diabetic Retinopathy Clinical Research clinical trials and compares the rates of noncompletion of the trial with the first data report (lost to follow-up). METHODS: This study is a retrospective cohort study of participants in Diabetic Retinopathy Clinical Research Retina Network clinical trials who met our inclusion criteria. The primary outcome was the lost to follow-up rates and their associated risk factors. RESULTS: Eight clinical trials with 3,492 participants met our inclusion criteria. Participants who were lost to follow-up were more likely to be younger, Hispanic or Black, had Type 1 diabetes mellitus, had worse baseline best-corrected visual acuity, had higher hemoglobin A1c, had higher blood pressure, and had proliferative diabetic retinopathy (PDR) (Diabetic Retinopathy Severity Score >66). CONCLUSION: Participants who were lost to follow-up during Diabetic Retinopathy Clinical Research clinical trials tended to be younger, Hispanic or Black, and had worse diabetes and hypertension. This study highlights the importance of ensuring that a representative population is maintained through the end of the study period.

Racial, Ethnic, and Gender Disparities in Diabetic Macular Edema Clinical Trials.

Subjects in diabetic macular edema clinical trials in the United States are disproportionately White and male, compared with the population undergoing treatment for diabetic macular edema.

Timing of Ocular Hypertension After Pediatric Closed-Globe Traumatic Hyphema: Implications for Surveillance.

PURPOSE: To evaluate the timing of ocular hypertension (OHT) after pediatric closed-globe injury (CGI) and traumatic hyphema. We hypothesize that OHT will occur at different times based on injury characteristics. DESIGN: Retrospective, cohort study. METHODS: Setting: Single-center, tertiary-care, pediatric hospital. PARTICIPANTS: Subjects included patients ≤18 years of age at the time of injury who suffered CGI and traumatic hyphema between 2002 and 2019. Observation Procedure(s): Intraocular pressure and injury demographics were abstracted for every visit after injury. OHT was defined as >21 mm Hg at presentation or after a reading of ≤21 mm Hg at a prior visit. MAIN OUTCOME MEASURES: The primary outcome measure was the timing of OHT categorized into 4 periods: presentation, acute (days 1-7), subacute (days 8-28), or late (day >28). Secondary outcome measures were identification of risks factors for OHT by multivariable logistic regression. RESULTS: OHT occurred in 119 of the 305 (39%) subject eyes. OHT occurred in 35 patients at presentation, 69 times acutely, 35 times subacutely, and 36 times late. Pupil damage predicted acute-period OHT (P = .004). OHT at presentation predicted subacute period OHT (P = .004). Iridodialysis and cataract predicted late-period OHT (P = .007 and P < .001, respectively). CONCLUSIONS: OHT after CGI and traumatic hyphema in pediatric patients is common. Injury demographics predict this complication. Integration of these risk factors with current literature allows proposal of a risk-stratification tool to guide efficient surveillance for OHT.

GEOGRAPHIC ACCESS DISPARITIES TO CLINICAL TRIALS IN RETINOPATHY OF PREMATURITY IN THE UNITED STATES.

BACKGROUND/PURPOSE: To identify geographic and socioeconomic variables predictive of residential proximity to retinopathy of prematurity (ROP) clinical trial locations. METHODS: This cross-sectional epidemiological study used census tract-level data from three national public data sets and trial-level data from ClinicalTrials.gov. Socioeconomic predictors of driving distance and time to the nearest ROP clinical trial location were identified. Primary outcomes were time >60 minutes and distance >60 miles traveled to the nearest ROP clinical trial site. RESULTS: Multivariate analysis showed that residents were more likely to travel >60 minutes to the nearest ROP clinical trial site if they lived in census tracts that were rural (adjusted odds ratio 1.20, P = 0.0002), had higher percentages of the population living ≤ federal poverty level (fourth quartile vs. first quartile, adjusted odds ratio 1.19, P < 0.0001), or had less education (associate vs. bachelor's degree, adjusted odds ratio 1.01, P <0.007). By contrast, counties with higher percentages of births with birth weight <1500 g (adjusted odds ratio 0.88, P = 0.0062) were less likely to travel >60 minutes. Similar variables predicted travel distance. CONCLUSION: Although counties with higher incidences of very low-birth-weight infants were closer to ROP clinical trial sites, residents living in rural and low-income census tracts had significantly greater travel burdens.

The Fovea in Retinopathy of Prematurity.

Purpose: Because preterm birth and retinopathy of prematurity (ROP) are associated with poor visual acuity (VA) and altered foveal development, we evaluated relationships among the central retinal photoreceptors, postreceptor retinal neurons, overlying fovea, and VA in ROP. Methods: We obtained optical coherence tomograms (OCTs) in preterm born subjects with no history of ROP (none; n = 61), ROP that resolved spontaneously without treatment (mild; n = 51), and ROP that required treatment by laser ablation of the avascular peripheral retina (severe; n = 22), as well as in term born control subjects (term; n = 111). We obtained foveal shape descriptors, measured central retinal layer thicknesses, and demarcated the anatomic parafovea using automated routines. In subsets of these subjects, we obtained OCTs eccentrically through the pupil (n = 46) to reveal the fiber layer of Henle (FLH) and obtained adaptive optics scanning light ophthalmograms (AO-SLOs) of the parafoveal cones (n = 34) and measured their spacing and distribution. Results: Both VA and foveal depth decreased with increasing ROP severity (term, none, mild, severe). In severe subjects, foveae were broader than normal and the parafovea was significantly enlarged compared to every other group. The FLH was thinner than normal in mild (but not severe) subjects. VA was associated with foveal depth more than group. Density of parafoveal cones did not differ significantly among groups. Conclusions: Foveal structure is associated with loss of VA in ROP. The preserved FLH in severe (relative to mild) eyes suggests treatment may help cone axon development. The significantly larger parafovea and increased outer nuclear layer (ONL) thickness in ROP hint that some developmental process affecting the photoreceptors is not arrested in ROP but rather is supranormal.

Virtual Visits in Ophthalmology: Timely Advice for Implementation During the COVID-19 Public Health Crisis.

Virtual visits (VVs) are necessitated due to the public health crisis and social distancing mandates due to COVID-19. However, these have been rare in ophthalmology. Over 3.5 years of conducting >350 ophthalmological VVs, our group has gained numerous insights into best practices. This communication shares these experiences with the medical community to support patient care during this difficult time and beyond. We highlight that mastering the technological platform of choice, optimizing lighting, camera positioning, and "eye contact," being thoughtful and creative with the virtual eye examination, and ensuring good documenting and billing will make a successful and efficient VV. Moreover, we think these ideas will stimulate further VV creativity and expertise to be developed in ophthalmology and across medicine. This approach, holds promise for increasing its adoption after the crisis has passed.

The current state of retinopathy of prematurity in India, Kenya, Mexico, Nigeria, Philippines, Romania, Thailand, and Venezuela.

Retinopathy of prematurity (ROP) is one of the leading causes of preventable blindness in children worldwide. Middle-income nations are currently experiencing epidemic levels of ROP, because greater access to neonatal intensive care units has improved survival rates of premature infants, but without sophisticated oxygen regulation. The epidemiology, screening infrastructure, treatment options, and challenges that these countries face are often tied to unique local socioeconomic, cultural, geopolitical, and medical factors. We present an overview and narratives of the current state of ROP in eight countries that are or soon will be experiencing ROP epidemics-India, Kenya, Mexico, Nigeria, Phillipines, Romania, Thailand, and Venezuela-with a view to fostering both an understanding of the differences in the ROP landscape in various settings and an interest in the further development of ROP screening and treatment services tailored to local requirements.