Evaluating VeriSee AI-Assisted Screening for Diabetic Retinopathy and Age-Related Macular Degeneration in Adults with Diabetes and Older Adults

What this Trial Is About

Diabetic retinopathy DR and age-related macular degeneration AMD are leading causes of vision loss, with increasing cases due to aging populations and more people with diabetes. This trial evaluates the VeriSee AI-assisted diagnostic software to improve screening for DR and AMD in adults with diabetes and older adults. The study, conducted at National Taiwan University Hospital, aims to assess both the clinical effectiveness and cost-effectiveness of this AI tool compared to standard physician-only screening. Participants are randomized into two groups one receives AI-assisted screening where fundus images are analyzed by VeriSee AI software with immediate results explained by physicians, and the other group undergoes standard screening with physician interpretation only after a follow-up visit. The study tracks ophthalmology referral outcomes, diagnostic results, and satisfaction from both patients and physicians from April 2025 to December 2027. Throughout the trial, participants undergo fundus photography and may be referred for further eye evaluation if abnormalities are found. Researchers collect data on the rate of detected cases needing treatments such as injections or laser therapy, and measure patient and physician satisfaction. The primary outcome is the proportion of confirmed cases requiring treatment within about one month from screening. This study aims to provide evidence on how AI-assisted screening may improve early detection and care for retinal diseases.

Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics