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

NCT06112691 | Unknown

• 1 other identifier: 24.01.2022
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy; Fundus photo; Artificail Intelligence; Diabetes Melitus; Screening; CheckEye; Fundus image; nonmydriatic camera

Outcome Measures

Primary Outcomes (1)

• The accuracy

  The accuracy of detecting of DR

  Baseline-Month 12

Secondary Outcomes (2)

• The percent of invalid images

  Baseline-Month 12

• The percent of false positive detection of DR

  Baseline-Month 12

Study Arms (2)

main group

diabetes mellitus

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

control group

without diagnosis of diabetes mellitus without retinal diseases

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

Interventions

taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock DEVICE

using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.

control group; main group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).
• 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

You may not qualify if:

• Patients under 18 years of age;
• Failure to give informed consent;
• 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.

Sponsors & Collaborators

• The Filatov Institute of Eye Diseases and Tissue Therapy: lead
• Komisarenko Institute of Endocrinology and Metobolism: collaborator
• CheckEye LLC: collaborator

Study Sites (1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Andrii MD Korol, PhD

  The Filatov Institute of Eye Diseases and Tissue Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrii MD Korol, PhD

CONTACT

380936327266; andrii.r.korol@gmail.com

Olha MD Pohosian

CONTACT

380932084927; olha.a.pohosian@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMedSc

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 1, 2023
• Study Start: February 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)