Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre

About this trial

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.

Eligibility criteria

Qualifiers

Adults (> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.

Disqualifiers

Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).

Life expectancy less than 6 months

Trial design

Treatments tested in this trial

  • Mobile retinography interpreted by artificial intelligence
  • Mobile retinography interpreted by ophthalmologists

Treatment groups

922 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital de Clinicas de Porto Alegre

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

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

Collaborator

TelessaúdeRS / UFRGS

Collaborator