ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study) (AIMDR)

The Filatov Institute of Eye Diseases and Tissue Therapy

Status: Enrolling

Conditions: Diabetic Retinopathy

Treatments: Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06112691

24.01.2022

Details and patient eligibility

About

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

Full description

The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.

This study is planned as a follow-up. Participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. After assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. Images will be taken according to a specific RAssbyAI Check Eye's imaging protocol provided to camera operator, and then analyzed by the RAssbyAI Check Eye's. The photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).

Enrollment: 660 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Documented diagnosis of Diabetes mellitus as defined by:

   A. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) B. Hemoglobin A1c (HbA1c)>= 6.5% based on repeated assessments C. Fasting Plasma Glucose (FPG) >= 126 mg/dL (7.0 mmol/L) based on repeated assessments D. Oral Glucose Tolerance test with 2 hr plasma glucose >= 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.

   E. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose >=200mg/dL (11.1 mmol/L).

2. Understanding of the Study and willingness and ability to sign informed consent

3. Patient age 18 or above

4. 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.
4. 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.

Trial design

660 participants in 2 patient groups

main group

Description:

diabetes mellitus

Treatment:

Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock

control group

Description:

without diagnosis of diabetes mellitus without retinal diseases

Treatment:

Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock