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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

RECRUITINGSponsored by Democritus University of Thrace
Actively Recruiting
SponsorDemocritus University of Thrace
Started2026-05-21
Est. completion2027-04-19
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07758582

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria Age ≥18 years Availability of a high-resolution color fundus photograph Confirmed diagnosis established by an ophthalmology specialist Exclusion Criteria Poor-quality retinal images Concomitant ocular diseases that interfere with image interpretation

Conditions2

DiabetesDiabetic Retinopathy

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