AI system for self-screening diabetic eye disease
AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
NA · The Hong Kong Polytechnic University · NCT06892353
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06892353 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using AI for screening purposes, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Hong Kong
- SPGC and Optometry Clinics — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Mingguang He
- Email: mingguang.he@polyu.edu.hk
- Phone: 85234002795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Retinopathy, diabetic retinopathy, AI, screening system