Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening (ARTDR)

The Filatov Institute of Eye Diseases and Tissue Therapy

Status

Enrolling

Conditions

Diabetic Retinopathy

Treatments

Device: taking fundus photos using non-mydriatic fundus camera

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06879834

02.10.2024

Details and patient eligibility

About

To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

Full description

Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Documented diagnosis of diabetes mellitus by definition.
Understanding of the Study and willingness and ability to sign informed consent
Patient age 18 or above
Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

Exclusion criteria

-1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.

A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.