MedTrace Logo

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

NCT07069647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4300

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Age-Related Macular Degeneration (AMD)
  • Diabetic Retinopathy (DR)

Interventions

OTHER

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).

OTHER

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.

Sponsors & Collaborators

  • Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • Fu Jen Catholic University Hospital

    collaborator OTHER

  • Min-Sheng General Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069647 on ClinicalTrials.gov