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Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics
Sponsor: National Taiwan University Hospital
Summary
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.
Official title: Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics: A Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4300
Start Date
2025-10-02
Completion Date
2027-12-31
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration
VeriSee DR is an AI-assisted diagnosis screening tool for diabetic retinopathy, the software received medical device license approval from the TFDA in 2020 (MOHW-MD-No.006966). VeriSee AMD is an AI-assisted diagnosis screening tool for age-related macular degeneration, the software also received medical device license approval from the TFDA in 2022 (MOHW-MD-No.007652).
Standard fundus photography with physician interpretation
The control group will undergo the fundus photography without AI-functionality, with reports interpreted solely by physicians. Participants must schedule a follow-up visit to receive their results.
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan