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| Name | Class |
|---|---|
| Komisarenko Institute of Endocrinology and Metobolism | OTHER_GOV |
| CheckEye LLC | INDUSTRY |
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The purpose of this study is to create a patient-centric environment for early detection of DR with AI-driven solutions.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main group | diabetes mellitus |
| |
| control group | without diagnosis of diabetes mellitus without retinal diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy | The accuracy of detecting of DR | Baseline-Month 12 |
| 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 |
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Inclusion Criteria:
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
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Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrii MD Korol, PhD | Contact | 380936327266 | andrii.r.korol@gmail.com | |
| Olha MD Pohosian | Contact | 380932084927 | olha.a.pohosian@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrii MD Korol, PhD | The Filatov Institute of Eye Diseases and Tissue Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Filatov Institute of Eye Diseases and Tissue Therapy | Recruiting | Odesa | 65061 | Ukraine |
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| Baseline-Month 12 |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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