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Published on: February 12, 2018
Vision-Related Patient-Reported Outcomes in Randomized Controlled Trials of Age-Related Macular Degeneration: A
Nicolas S Bodmer1,2, Melisa Guezelguen3, Leyla Huber4
1Institute of Epidemiology, Biostatistics and Prevention, University of Zurich, Zurich, Switzerland.
Ophthalmology Science
|August 8, 2026
Summary
Patient-reported outcome measures (PROMs) in age-related macular degeneration (AMD) trials show inconsistent reporting. Standardizing PROM selection and baseline data is crucial for better patient-centered research and evidence synthesis in AMD.
Area of Science:
- Ophthalmology
- Clinical Research Methodology
- Patient-Reported Outcomes
Background:
- Age-related macular degeneration (AMD) significantly impacts daily functioning and quality of life, extending beyond visual acuity.
- Inconsistent use and reporting of patient-reported outcome measures (PROMs) in AMD clinical trials hinder interpretation and evidence synthesis.
Purpose of the Study:
- To systematically review the selection, operationalization, and baseline reporting of vision-related PROMs in randomized controlled trials (RCTs) for patients with age-related macular degeneration (AMD).
Main Methods:
- Systematic search of major databases (MEDLINE, Embase, Web of Science, Scopus) up to September 2023, with an update for 2024-2025 publications.
- Included RCTs involved ≥20 participants with AMD and reported baseline visual acuity and PROM data.
- Data extracted included PROM selection, scoring, baseline distributions, laterality, and subgroup reporting, followed by descriptive synthesis.
Main Results:
- Thirty-eight RCTs across AMD stages were analyzed, utilizing 11 distinct PROMs, with the NEI VFQ family being most common (78.9%).
- Baseline functional status varied by AMD stage, with earlier stages showing higher scores and neovascular AMD showing lower, heterogeneous scores.
- Reporting was inconsistent, with limited subscale/domain data, no subgroup analysis, and incomplete eye-specific visual function reporting (only 13% reported both eyes).
Conclusions:
- Inconsistent baseline PROM reporting and lack of binocular vision data limit the interpretability of findings in AMD trials.
- Standardizing stage-appropriate PROM selection and consistently reporting baseline distributions are essential for patient-centered evaluation in AMD research.