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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | June 30, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | March 24, 2025 |
| Trial ID | NCT06892353 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
- Study coordinator: Mingguang He
- Email: mingguang.he@polyu.edu.hk
- Phone: 85234002795
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy
This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.
-
Automated detection of diabetic retinopathy lesions in fundus photos
This study tests a smart imaging system within the DDART device to see if it can reliably spot diabetic retinopathy lesions in color fundus photographs.
-
Retinal microvascular changes in diabetic retinopathy measured with OCTA
This observational study tests how retinal blood vessel patterns seen on OCTA relate to vision and blood sugar control in adults with diabetic retinopathy.
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MK-8748 vs. aflibercept for diabetic macular edema
This trial tests whether the investigational medicine MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in adults with diabetes.
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MK-8748 vs aflibercept for diabetic macular edema
This trial tests whether MK-8748 can treat diabetic macular edema as well as the standard treatment aflibercept in people with diabetes.
-
Surabgene Lomparvovec in the Suprachoroidal Space for Diabetic Retinopathy
This study tests a one-time gene therapy called surabgene lomparvovec to see if it can help adults with non-proliferative diabetic retinopathy avoid vision-threatening events.
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.