NCT07069647 Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics
| NCT ID | NCT07069647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Age-Related Macular Degeneration (AMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,300 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above. * VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above. Exclusion Criteria: * The patient does not agree to participate in the trial or is unable to provide informed consent.