Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care (AID-DR)

November 17, 2025 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

922

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Fernando K Malerbi, MD, PhD
        • Principal Investigator:
          • Caio Vinicius Regatieri, MD, PhD
        • Principal Investigator:
          • Dimitris RV Rados, MD, PhD
        • Sub-Investigator:
          • Greice Caletti, PhD
        • Principal Investigator:
          • Jeruza L Neyeloff, MD, PhD
        • Sub-Investigator:
          • Luis Filipe Nakayama, MD
        • Principal Investigator:
          • Natan Katz, MD, PhD
        • Sub-Investigator:
          • Gabriel Leivas, MD
        • Sub-Investigator:
          • Josiane Schneiders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RDIA group
The proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.
Diagnostic test: Mobile retinography interpreted by artificial intelligence
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.
Active Comparator: RDOF group
The proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.
Diagnostic test: Mobile retinography interpreted by ophthalmologists
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
After study completion, an average of 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

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

Investigators

  • Principal Investigator: Beatriz D Schaan, MD, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 4, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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