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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDemocritus University of Thrace

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Participants that are able to provide consent for their fundus photograph to be recorded

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Color retinal fundus photograph

    Diagnostic test

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

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Participants from outpatient clinics1 intervention

Trial outcomes

Primary outcomes

1

Validation 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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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