Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07236879

Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care

This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location status: Recruiting

Location contact

Beatriz D Schaan, MD, PhD

CONTACT

[email protected]

+55 51 3359-8127

Caio Vinicius Regatieri, MD, PhD

PRINCIPAL_INVESTIGATOR

Dimitris RV Rados, MD, PhD

PRINCIPAL_INVESTIGATOR

Fernando K Malerbi, MD, PhD

PRINCIPAL_INVESTIGATOR

Gabriel Leivas, MD

SUB_INVESTIGATOR

Greice Caletti, PhD

SUB_INVESTIGATOR

Jeruza L Neyeloff, MD, PhD

PRINCIPAL_INVESTIGATOR

Josiane Schneiders

SUB_INVESTIGATOR

Luis Filipe Nakayama, MD

SUB_INVESTIGATOR

Natan Katz, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile retinography interpreted by artificial intelligence

Diagnostic Test

All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDIA group, their photos will be analyzed by artificial intelligence.

Mobile retinography interpreted by ophthalmologists

Diagnostic Test

All participants will undergo mobile retinal photography in primary care by a trained nursing assistant. If randomized to RDOF group, their photos will be interpreted remotely by ophthalmologists.

Primary outcomes

  1. Number of appropriate referrals to ophthalmologist

    Time frame: Through study completion, an average of 1 year

    Appropriate referrals: asymptomatic patients with moderate to severe nonproliferative DR, proliferative DR, significant macular edema, and uninterpretable exams. This data will be obtained by reviewing the medical records of ophthalmological in-person consults of included patients.

Secondary outcomes

  1. Number of patients referred for laser sessions

    Time frame: Through study completion, an average of 1 year

    Considering only patients referred for argon laser sessions aiming retinal photocoagulation for the treatment of diabetic retinopathy. This data will be obtained through access to the medical records of patients referred for specialized care.

  2. Number of pharmacological intraocular treatment

    Time frame: Through study completion, an average of 1 year

    Considering treatment with anti-VEGF drugs or intravitreal corticosteroids for the treatment of diabetic retinopathy and diabetic macular edema. This data will be obtained through access to the medical records of patients referred for specialized care.

  3. Referral failure

    Time frame: After study completion, an average of 15 months

    Screening with false negative result. This data will be obtained by an independent ophthalmologist review of all images of the not referred patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz D Schaan, MD, PhD

CONTACT

[email protected]

+55 51 3359-8127

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
  • TelessaúdeRS / UFRGS

Registry information

Official study title

Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes

Acronym: AID-DR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.