Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Diabetic Retinopathy trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment922 (estimated)
SponsorHospital de Clinicas de Porto Alegre
Academic / other
Locations1 site (Porto Alegre, Rio Grande do Sul)
StatusRecruiting
StartedAugust 8, 2024
Main results expectedAugust 2026
Study endsDecember 2026
Registry record updatedNovember 19, 2025
Trial IDNCT07236879 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

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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.