Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07758569

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Greece

Location status: Recruiting

Location contact

Georgios Labiris

CONTACT

[email protected]

+302551030990

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years. Availability of a high-resolution color fundus photograph. Confirmed diagnosis established by a specialist.

Exclusion criteria

  • Poor-quality images. Coexisting ocular diseases that interfere with image interpretation.

Treatment and study plan

Color fundus photograph

Diagnostic Test

Color retinal fundus photographs will be acquired from:

Digital non-mydriatic fundus cameras.

Primary outcomes

  1. Validation of the sensitivity and specificity of the artificial intelligence subsystem for AMD detection

    Time frame: 1 year

  2. Validation of the sensitivity and specificity of the artificial intelligence subsystem for diabetic retinopathy detection

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Labiris

CONTACT

[email protected]

+302551030990

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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 Photograph

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.