Retinal Clinical Assessment With AI-derived Quantitative Information

This randomized controlled trial evaluates whether providing clinicians with AI-derived quantitative retinal information improves the quality and efficiency of retinal clinical assessment. Participating ophthalmologists and ophthalmology trainees will be randomly assigned to one of two groups. The intervention group will write clinical reports with access to automated quantitative measurements generated from fundus image analysis, including multiple retinal structural and vascular biomarkers. The control group will complete the same reporting tasks using only the original fundus images without AI-generated quantitative information. All reports produced by both groups will be de-identified and independently evaluated by a separate panel of senior ophthalmologists who are blinded to group allocation. The expert evaluators will assess report accuracy, completeness, clarity, and overall clinical quality using predefined scoring criteria. The study aims to determine whether access to quantitative retinal biomarkers enhances clinicians' reporting performance and reduces reporting time during retinal assessment tasks.

NCT Number	NCT07291960
Lead Sponsor	Beijing Tongren Hospital
Conditions	no Obvious Abnormalities, Diabetic Retinopathy (DR), AMD, Cup-to-disc Ratio Bigger Than 0.5, Pathological Myopia, Macular Hole, Epiretinal Membrane, Retinal Vein Occlusion (RVO)
Enrollment	29 participants
Start Date	2026-04-15
Primary Completion	2026-05-15 (estimated)
Study Completion	2026-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-29