Demographic and Socioeconomic Factors in Prospective Retina-Focused Clinical Trial Screening and Enrollment.

Historically marginalized populations are disproportionately affected by many diseases that commonly affect the retina, yet they have been traditionally underrepresented in prospective clinical trials. This study explores whether this disparity affects the clinical trial enrollment process in the retina field and aims to inform future trial recruitment and enrollment. Age, gender, race, ethnicity, preferred language, insurance status, social security number (SSN) status, and median household income (estimated using street address and zip code) for patients referred to at least one prospective, retina-focused clinical trial at a large, urban, retina-based practice were retrospectively extracted using electronic medical records. Data were collected for the 12-month period from 1 January 2022, through 31 December 2022. Recruitment status was categorized as Enrolled, Declined, Communication (defined as patients who were not contacted, were contacted with no response, were waiting for a follow-up, or were scheduled for screening following a clinical trial referral.), and Did Not Qualify (DNQ). Univariable and multivariable analyses were used to determine significant relationships between the Enrolled and Declined groups. Among the 1477 patients, the mean age was 68.5 years old, 647 (43.9%) were male, 900 (61.7%) were White, 139 (9.5%) were Black, and 275 (18.7%) were Hispanic. The distribution of recruitment status was: 635 (43.0%) Enrolled, 232 (15.7%) Declined, 290 (19.6%) Communication, and 320 (21.7%) DNQ. In comparing socioeconomic factors between the Enrolled and Declined groups, significant odds ratios were observed for age (p < 0.02, odds ratio (OR) = 0.98, 95% confidence interval (CI) [0.97, 1.00]), and between patients who preferred English versus Spanish (p = 0.004, OR = 0.35, 95% CI [0.17, 0.72]. Significant differences between the Enrolled and Declined groups were also observed for age (p < 0.05), ethnicity (p = 0.01), preferred language (p < 0.05), insurance status (p = 0.001), and SSN status (p < 0.001). These factors may contribute to patient participation in retina-focused clinical trials. An awareness of these demographic and socioeconomic disparities may be valuable to consider when attempting to make clinical trial enrollment an equitable process for all patients, and strategies may be useful to help address these challenges.

Visual Acuity Variability: Comparing Discrepancies between Snellen and ETDRS Measurements among Subjects Entering Prospective Trials.

PURPOSE: To compare the variability between Snellen visual acuity (VA) and Early Treatment Diabetic Retinopathy (ETDRS) best-corrected VA (BCVA) measurements. DESIGN: Retrospective chart review. PARTICIPANTS: Eyes from subjects entering 12 prospective retinal trials in a large, urban retina practice. METHODS: Eyes were included if a Snellen VA measurement was performed at the visit preceding trial screening and VA was better than counting fingers. Snellen VA and ETDRS BCVA were then converted to logarithm of the minimum angle of resolution (logMAR) units, and the variability between measurements was calculated. MAIN OUTCOME MEASURES: Outcome measures include VA variability among disease states, absolute VA, and central subfield thickness (CST). RESULTS: A total of 773 eyes of 413 subjects were identified with a mean of 27.2 days (median, 19; 95% confidence interval [CI], 25.1-29.3) between measurements. Mean Snellen and ETDRS measurements were 0.40 (20/50) and 0.27 logMAR (20/40), respectively. Overall, mean ETDRS BCVA was 6.1 letters better than Snellen VA (median, 5.8; 95% CI, 5.3-7.0; P < 0.05); 76.6% of eyes had improved ETDRS. Restricting the number of days between measurements did not result in any meaningful differences from this directionality. Among eyes with worse VA, variation was more pronounced than among eyes with better VA; eyes 20/25 or better were a mean +1.9 letters better on ETDRS testing (P < 0.05) and eyes 20/160 or worse were a mean +12.6 letters better on ETDRS testing (P < 0.05). Subgroup analyses by disease state found statistically significantly better vision measurements with the ETDRS protocol compared with Snellen in 4 of the 5 disease states studied. Although lens status did not affect the extent of discrepancy between ETDRS and Snellen measurements, amount of retinal edema (CST) did: increased CST correlated with increased variability. CONCLUSIONS: The ETDRS protocol BCVA measurement resulted in significantly better scores when compared with Snellen VA measurements. This difference was more pronounced among eyes with worse VA. Additionally, specific retinal disease states and anatomic variables such as extent of retinal edema (CST) may have a meaningful impact on the anticipated variability between ETDRS and Snellen VA measurement.