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Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care

NCT07236879 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 922

Last updated 2025-11-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

    collaborator OTHER

  • TelessaúdeRS / UFRGS

    collaborator UNKNOWN

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Beatriz D Schaan, MD, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236879 on ClinicalTrials.gov