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

Recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock

• Registration Number: NCT06112691
• Lead Sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2023-06
• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-10-29
• Last Update Submitted: 2023-10-29
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock	without diagnosis of diabetes mellitus without retinal diseases
main group	taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock	diabetes mellitus

Primary Outcome Measures

Name	Time	Method
The accuracy	Baseline-Month 12	The accuracy of detecting of DR

Secondary Outcome Measures

Name	Time	Method
The percent of invalid images	Baseline-Month 12	The percent of invalid images for analysing by neural network
The percent of false positive detection of DR	Baseline-Month 12	The percent of false positive detection of DR in individuals without DR

Trial Locations

Locations (1)

The Filatov Institute of Eye Diseases and Tissue Therapy; 🇺🇦 Odessa, Ukraine