MedTrace Logo

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

NCT07758582 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2026-08-11

No results posted yet for this study

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

Conditions

Interventions

DIAGNOSTIC_TEST

Color retinal fundus photograph

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

Sponsors & Collaborators

  • Democritus University of Thrace

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-21
Primary Completion
2027-04-19
Completion
2027-04-19

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758582 on ClinicalTrials.gov