Status:
UNKNOWN
ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)
Lead Sponsor:
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborating Sponsors:
Komisarenko Institute of Endocrinology and Metobolism
CheckEye LLC
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-90 years
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 cr...
Eligibility Criteria
Inclusion
- 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
- \-
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06112691
Start Date
February 1 2022
End Date
November 1 2024
Last Update
November 1 2023
Active Locations (1)
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1
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061