Vision-Related Patient-Reported Outcomes in Randomized Controlled Trials of Age-Related Macular Degeneration: A Systematic Review

This is the authors' abstract. We don't add key points for this paper.

Purpose: To characterize the utilization, operationalization, and baseline reporting of visionrelated patient-reported outcome measures (PROMs) in randomized controlled trials (RCTs) for age-related macular degeneration (AMD). Methods: A systematic search of MEDLINE, Embase, Web of Science Core Collection, and Scopus was conducted from database inception to September 27, 2023, supplemented by a targeted update for relevant 2024 and 2025 publications.Eligible studies were randomized controlled trials enrolling at least 20 participants with AMD and reporting both baseline visual acuity and baseline vision-related PROM data.Data on PROM instrument selection, scoring, baseline distributions, laterality context, and subgroup reporting were extracted and synthesized descriptively.Results: Thirty-eight RCTs met the inclusion criteria, spanning early through late-stage AMD.Across included trials, 11 distinct PROM instruments were reported.The National Eye Institute Visual Function Questionnaire (NEI VFQ) family predominated (78.9%), with the NEI VFQ-25 being the most commonly used version (n=17).Baseline patient-reported functional statusvaried by disease stage: early and intermediate AMD cohorts reported higher scores (75.3-89.1),whereas trials enrolling neovascular AMD patients showed lower and more heterogeneous scores (59.1-77.9).Subscale/domain reporting was inconsistent, with many trials presenting only composite scores or a limited subset of subscales.Baseline PROM resultswere not reported by subgroup, preventing comparisons across patient populations.Reporting of visual function was incomplete with only 13% of studies reporting both better-and worseseeing eyes. Conclusion:The interpretive value of PROMs in AMD trials is constrained by inconsistent baseline reporting and limited reporting of both-eye and binocular acuity needed to contextualize patient-level function.Enhanced consistency in stage-appropriate PROM