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

August 6, 2026 updated by: Georgios Labiris, Democritus University of Thrace

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Alexandroupoli, Greece
        • Recruiting
        • University Hospital of Alexandroupolis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of the sensitivity and specificity of the artificial intelligence subsystem for AMD detection
Time Frame: 1 year
1 year
Validation of the sensitivity and specificity of the artificial intelligence subsystem for diabetic retinopathy detection
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

April 19, 2027

Study Completion (Estimated)

April 19, 2027

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 6, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17756/01-04-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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