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Abstract #127978 Published in IGR 25-3
Differential Sex-Based Enrolment into US-Registered Glaucoma Clinical Trials: A Cross-Sectional Study
Tao BK; Xie JS; Vinokurtseva A; Liu J; Suntharalingam H; Xia M; Nathoo N; Schlenker M; Gill K; Hutnik CMLSeminars in Ophthalmology 2025; 0: 1-5
PURPOSE: We conducted a cross-sectional study of sex, racial, and ethnic patient enrolment to glaucoma-related randomized controlled trials (RCTs) registered on ClinicalTrials.gov (to January 2023). METHODS: Trials were included if they were at least double-masked, completed, and had published results through the registry or a scholarly journal. Sex-based glaucoma disease burden was identified using the Global Burden of Disease database. Pooled population-to-prevalence ratios (PPRs) with 95% confidence intervals (CI) were calculated for female sex, with values between 0.8 and 1.2 constituting sufficient study enrolment. RESULTS: From 1061 records, we identified 177 trials ( = 38.475; 56.2% females) for inclusion in the study. The pooled female PPR was 1.05 [95% CI 1.02, 1.08]. Sub-group analysis revealed equitable female enrolment across study characteristics, although studies published prior to 1997 were indeterminate on whether they under-enrolled female participants. CONCLUSIONS: Overall, US-registered, glaucoma-related trials enrolled acceptable proportions of females based on real-world disease burden. Future trial enrolment should strive for equitable demographic representation.
Department of Ophthalmology & Vision Science, University of Toronto, Toronto, ON, Canada.
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