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

Sponsor
Democritus University of Thrace
Study ID
NCT07758569
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • color fundus photograph — DIAGNOSTIC_TEST
    Color retinal fundus photographs will be acquired from: Digital non-mydriatic fundus cameras.

Study Details

Primary Objective To validate the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with glaucoma in a random sample of retinal fundus photographs.

Key Dates

First listed
Aug 11, 2026
Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Apr 19, 2027
Completion
Apr 19, 2027

Study Design

Enrollment
2,000 participants (estimated)

Primary Outcome Measure

Validation of the sensitivity and specificity of the artificial intelligence subsystem for AMD detection [ Time Frame: 1 year ]

Central Contacts

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