Clinical trial Recruiting at 1 site Interventional Ages 18 and up

AI system for self-screening diabetic eye disease

Official title: AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial

Run by The Hong Kong Polytechnic University · NCT06892353 · Data updated 2026-11-12

This study is testing a new AI system that lets people with diabetes check their own eyes for signs of eye disease to see how well it works in different clinic settings.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorThe Hong Kong Polytechnic University
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedJune 30, 2025
Study endsJuly 31, 2025
Registry record updatedMarch 24, 2025
Trial IDNCT06892353 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 50 and older or those 18 and older with diabetes who have not had an eye examination in the past year.

Probably not a fit

Patients with physical disabilities that hinder the use of a fundus camera or those with speech impairments unable to complete follow-ups may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates an AI-powered DIY screening system for diabetic retinopathy in various clinic settings. Over a three-month period, participants will use an automated fundus camera for self-screening, followed by physician consultations and surveys. The study aims to assess the system's success rate, accuracy, screening and detection rates, adherence to referrals, participant experience, and cost-effectiveness in real-world scenarios. A total of up to 500 patients will be involved across different clinics.

Why it matters

Potential benefit: If successful, this approach could enable early detection of diabetic retinopathy, improving patient outcomes and reducing vision loss.

How similar studies have gone: Other studies have shown promise in using AI for screening purposes, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
3. Provide written informed consent.

Exclusion Criteria:

1. individuals with physical disabilities that prevent the use of a fundus camera, or
2. individuals with speech impairments who are unable to complete telephone follow-ups.

Where it's running

  • SPGC and Optometry Clinics
    Hong Kong, Hong Kong
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.