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
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