ARTIFICIAL INTELLIGENCE FOR MASS SCREENING OF THE DIABETIC RETINOPATHY IN THE CHERNIVTSI REGION (Pilot Study)
NCT ID: NCT06112691
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
660 participants
OBSERVATIONAL
2022-02-01
2024-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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main group
diabetes mellitus
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
taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
Interventions
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taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
Yes
Sponsors
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Komisarenko Institute of Endocrinology and Metobolism
OTHER_GOV
CheckEye LLC
INDUSTRY
The Filatov Institute of Eye Diseases and Tissue Therapy
OTHER
Responsible Party
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Andrii Korol, MD, PhD
MD, PhD, DMedSc
Principal Investigators
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Andrii MD Korol, PhD
Role: PRINCIPAL_INVESTIGATOR
The Filatov Institute of Eye Diseases and Tissue Therapy
Locations
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The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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24.01.2022
Identifier Type: -
Identifier Source: org_study_id
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