Outcomes Evaluated in Randomized Controlled Trials of Treatments for Dry Eye: A Systematic Review.

PURPOSE: To initiate the process of core outcome set development for dry eye disease (DED) by conducting a systematic review of all outcomes in randomized controlled trials (RCTs) of treatments for DED. A core outcome set is an agreed-upon minimum set of outcomes that should be measured and reported in all clinical trials in a topic area. METHODS: We searched PubMed and Embase from January 1, 2016 to January 3, 2024 for RCTs of treatments for DED. Post hoc , we decided to focus on recent evidence and excluded RCTs published before 2016. Two independent investigators screened titles and abstracts (initially) and full-text articles (subsequently), resolving conflicts through discussion. We refined a previously developed outcome taxonomy for DED. We extracted all outcome domains and measurement instruments used for those domains in the included sample of RCTs. RESULTS: Our searches identified 6477 unique records, and we included 300 RCTs. The most frequently used outcome domains across all RCTs were tear film stability (90.6% of RCTs), overall assessment of ocular symptoms (84.3%), corneal staining score (75.7%), tear production (66.0%), conjunctival staining score (39.7%), visual acuity (35.0%), meibomian gland plugging/clogging grade (27.0%), inferior tear film meniscus height (16.0%), and adverse events (28.0%). There was considerable inconsistency regarding measurement instruments. CONCLUSIONS: Variability in outcome measures and instruments used underscores the need for a core outcome set for DED. Our next steps are to begin prioritizing the identified outcomes for a core outcome set for DED.

Duke Scholars

Author Esen Karamursel Akpek Ophthalmology, Vitreoretinal Diseases & Surgery