Clinical trial NCT06112691: ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)
Official title: USING ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Keywords: Diabetic Retinopathy
Fundus photo
Artificail Intelligence
Diabetes Melitus
Screening
CheckEye
Fundus image
nonmydriatic camera
Lead sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
Sponsor class: OTHER
Collaborators: name: Komisarenko Institute of Endocrinology and Metobolism
name: CheckEye LLC
First posted: 2023-11-01
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy
timeFrame: Baseline-Month 12
Secondary outcomes:
measure: The percent of invalid images
timeFrame: Baseline-Month 12
measure: The percent of false positive detection of DR
timeFrame: Baseline-Month 12
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: The Filatov Institute of Eye Diseases and Tissue Therapy
Study officials:
affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy
name: Andrii MD Korol, PhD
role: PRINCIPAL_INVESTIGATOR
References: