Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults (\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.
Locations
Other Locations
Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Beatriz D Schaan, MD, PhD
bschaan@hcpa.edu.br
+55 51 3359-8127
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 922
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
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
Leads: Hospital de Clinicas de Porto Alegre