Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care
ConditionDiabetic Retinopathy
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mobile retinography interpreted by artificial intelligence
Diagnostic testAll 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 testAll 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.
Treatment groups
922 Participants
are divided into 2 treatment groupsGroup A: RDIA groupExperimental treatment 1 intervention
Group B: RDOF groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of appropriate referrals to ophthalmologist
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Number of patients referred for laser sessions
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.
Time frame
Through study completion, an average of 1 year2
Number of pharmacological intraocular treatment
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.
Time frame
Through study completion, an average of 1 year3
Referral failure
Screening with false negative result. This data will be obtained by an independent ophthalmologist review of all images of the not referred patients.
Time frame
After study completion, an average of 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov