AI reading retinal photos for diabetic eye screening in primary care
Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
NA · Hospital de Clinicas de Porto Alegre · NCT07236879
This trial tests whether an artificial intelligence program can read retinal photos taken in primary care to screen adults with diabetes for diabetic retinopathy and macular edema instead of relying on ophthalmologists' reads.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 922 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre (other) |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT07236879 on ClinicalTrials.gov |
What this trial studies
Trained nursing assistants use a portable fundus camera in a primary care clinic to obtain retinal photographs from adults with diabetes. Images are read either by an artificial intelligence algorithm or by ophthalmologists, and the results are compared for detection of diabetic retinopathy and diabetic macular edema. The comparison includes diagnostic concordance, referral recommendations, and feasibility of implementing universal screening in the primary care workflow. Participants with contraindications to pupil dilation or short life expectancy are excluded.
Who should consider this trial
Good fit: Adults aged over 18 with diabetes who agree to participate and can undergo pupil dilation are the ideal candidates for this protocol.
Not a fit: People with contraindications to pharmacologic mydriasis (for example known closed-angle glaucoma or pregnancy) or with a life expectancy under six months may not receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could increase access to timely diabetic eye screening in primary care and speed referrals to eye specialists.
How similar studies have performed: Previous research has shown AI algorithms can detect diabetic retinopathy from fundus images with high sensitivity and specificity, though performance can vary by camera type and care setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study. Exclusion Criteria: * Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy). * Life expectancy less than 6 months
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (RECRUITING)
Study contacts
- Principal investigator: Beatriz D Schaan, MD, PhD — Hospital de Clínicas de Porto Alegre
- Study coordinator: Beatriz D Schaan, MD, PhD
- Email: bschaan@hcpa.edu.br
- Phone: +55 51 3359-8127
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, screening, diabetic retinopathy, artificial intelligence