RecruitingNCT07758582

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


Sponsor

Democritus University of Thrace

Enrollment

2,000 participants

Start Date

May 21, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Color retinal fundus photograph for people with diabetic retinopathy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTColor retinal fundus photograph

Diagnostic Test: color fundus photograph Description: Color retinal fundus photographs will be acquired from: Digital non-mydriatic fundus cameras.


Locations(1)

University Hospital of Alexandroupolis

Alexandroupoli, Greece

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NCT07758582


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