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

USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock

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 Type: Observational
• Enrollment (Estimated): 660

Contacts and Locations

• Study Contact: Name: Andrii MD Korol, PhD; Phone Number: 380936327266; Email: andrii.r.korol@gmail.com
• Study Contact Backup: Name: Olha MD Pohosian; Phone Number: 380932084927; Email: olha.a.pohosian@gmail.com

Study Locations

• Ukraine
  • Odessa, Ukraine, 65061
    • Recruiting
    • The Filatov Institute of Eye Diseases and Tissue Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

660 participants were planed to include in study, 410 of them had diabetes mellitus and 250 participants were as a control group without diagnosis of diabetes mellitus.

All participants were selected for the study based on the following inclusion and exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
main group; diabetes mellitus	Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock; using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
control group; without diagnosis of diabetes mellitus without retinal diseases	Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock; using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy	The accuracy of detecting of DR	Baseline-Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent of invalid images	The percent of invalid images for analysing by neural network	Baseline-Month 12
The percent of false positive detection of DR	The percent of false positive detection of DR in individuals without DR	Baseline-Month 12

Collaborators and Investigators

• Sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
• Collaborators: Komisarenko Institute of Endocrinology and Metobolism; CheckEye LLC
• Investigators: Principal Investigator: Andrii MD Korol, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Diabetic Retinopathy; Fundus photo; Artificail Intelligence; Diabetes Melitus; CheckEye; Fundus image; nonmydriatic camera
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 24.01.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No