AI-assisted eye screening for diabetic retinopathy and age-related macular degeneration in outpatient clinics
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
Run by National Taiwan University Hospital · NCT07069647 · Data updated 2026-11-12
This project will test whether the VeriSee AI software helps doctors find diabetic eye disease and macular degeneration earlier in adults with diabetes or people aged 50 and older.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 4300 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07069647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with diabetes aged 20 and older or adults aged 50 and above who meet AMD screening criteria and can provide informed consent at participating outpatient clinics.
✕Probably not a fit
Patients who already have advanced retinal disease under active ophthalmology care, those with ungradable fundus images, or those unable to consent are unlikely to benefit from the screening intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized controlled trial at National Taiwan University Hospital comparing AI-assisted fundus-photo screening using VeriSee plus immediate physician explanation versus standard physician-only fundus interpretation. Adults with diabetes (age 20+) and adults aged 50+ who meet AMD screening criteria are randomized to one of the two screening approaches. Primary outcomes include detection rates of diabetic retinopathy and AMD, subsequent ophthalmology referrals and outcomes, patient and physician satisfaction, and a parallel cost-effectiveness analysis. Data collection is planned from April 2025 through December 2027 across the main and Bei-Hu hospital branches.
Why it matters
Potential benefit: If successful, the AI-assisted screening could increase early detection of sight-threatening eye disease and reduce late-stage vision loss and related healthcare costs.
How similar studies have gone: Previous studies of AI-based fundus screening have shown good diagnostic accuracy and improved detection rates in primary-care settings, so this trial builds on promising prior work.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Taiwan University Hospital
Taipei, Taiwan Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment
This project will test whether proteins found in blood and eye fluids can help diagnose or predict outcomes for adults with AMD, diabetic retinopathy, or retinal detachment.
-
VeriSee AI for screening macular degeneration and diabetic retinopathy
This trial will test whether the VeriSee AI software can help doctors screen for age-related macular degeneration in adults 50+ and diabetic retinopathy in diabetic adults 20+.
-
Automated AI system to detect diabetic retinopathy in adults with diabetes
A AI-based software device is being tested to automatically detect diabetic retinopathy from retinal images in adults with diabetes.
-
N-acetylcysteine for diabetic retinopathy in adults with type 2 diabetes
This study tests whether taking N-acetylcysteine for three months can help people with type 2 diabetes who have mild to moderate diabetic retinopathy.
-
Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
-
Enhanced vision and imaging tests to enable treatments for early and intermediate AMD
We will see if a fundus-tracked dark adaptometry test can reliably detect and track vision changes in people with early or intermediate AMD and in healthy volunteers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.