Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care (AID-DR)

Hospital de Clinicas de Porto Alegre

Status: Enrolling

Conditions: Diabetic Retinopathy

Treatments: Diagnostic Test: Mobile retinography interpreted by ophthalmologists; Diagnostic Test: Mobile retinography interpreted by artificial intelligence

Study type: Interventional

Funder types: Other

Identifiers

NCT07236879

2024-0238

Details and patient eligibility

About

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.

Enrollment: 922 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).
• Life expectancy less than 6 months

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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922 participants in 2 patient groups

RDIA group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Mobile retinography interpreted by artificial intelligence

RDOF group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Mobile retinography interpreted by ophthalmologists