NCT07758569

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Apr 2027

Study Start

First participant enrolled

April 21, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2027

Last Updated

August 11, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

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

    1 year

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

    1 year

Interventions

color fundus photographDIAGNOSTIC_TEST

Color retinal fundus photographs will be acquired from: Digital non-mydriatic fundus cameras.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Greece

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Georgios Labiris

CONTACT

+302551030990glampiri@med.duth.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Democritus University of Thrace

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

April 21, 2026

Primary Completion (Estimated)

April 19, 2027

Study Completion (Estimated)

April 19, 2027

Last Updated

August 11, 2026

Record last verified: 2026-04

Locations

GR(1)