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

Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient/physician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.

NCT Number	NCT07069647
Lead Sponsor	National Taiwan University Hospital Collaborators: Ministry of Health and Welfare, Taiwan, Fu Jen Catholic University Hospital, Min-Sheng General Hospital
Conditions	Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR)
Enrollment	4,300 participants
Start Date	2025-10-02
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-22