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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07758569

Enrollment

2000

Registered

2026-08-11

Start date

2026-04-21

Completion date

2027-04-19

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DIAGNOSTIC_TESTcolor fundus photograph

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Greece

Contacts

CONTACTGeorgios Labiris

glampiri@med.duth.gr+302551030990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026