AI reading retinal photos for diabetic eye screening in primary care
Official title: Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
Run by Hospital de Clinicas de Porto Alegre · NCT07236879 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 922 (estimated) |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Status | Recruiting |
| Started | August 8, 2024 |
| Main results expected | August 2026 |
| Study ends | December 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07236879 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged over 18 with diabetes who agree to participate and can undergo pupil dilation are the ideal candidates for this protocol.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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 Clinicas de Porto Alegre
- Study coordinator: Beatriz D Schaan, MD, PhD
- Email: bschaan@hcpa.edu.br
- Phone: +55 51 3359-8127
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
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.
-
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.
-
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.