Validation of the Artificial Intelligence Subsystem of the DDART Medical Device for the Automated Detection of Lesions Compatible With Diabetic Retinopathy in a Random Sample of Retinal Fundus Photographs

Brief summary (registry, in English)

To validate the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with diabetic retinopathy in a random sample of retinal fundus photographs. Secondary Objectives To determine the sensitivity and specificity of the artificial intelligence subsystem for the detection of diabetic retinopathy. To estimate the overall diagnostic accuracy and the area under the receiver operating characteristic (ROC) curve (AUC). To compare the performance of the algorithm with that of experienced ophthalmologists. To evaluate the ability of the model to distinguish between different stages of disease severity

What you commit to

• Study type: Observational
• Planned participants: 2000
• From 21 May 2026 to the primary completion date, 19 Apr 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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