An observational study in Diabetic Retinopathy, sponsored by The Filatov Institute of Eye Diseases and Tissue Therapy. Recruiting at 1 site in Ukraine. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by The Filatov Institute of Eye Diseases and Tissue Therapy · Observational
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).
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 660 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →The Filatov Institute of Eye Diseases and Tissue Therapy is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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).
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Exclusion Criteria:
diabetes mellitus
Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
without diagnosis of diabetes mellitus without retinal diseases
Device: taking fundus photos using non-mydriatic fundus camera - FundusScope Rodenstock
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
The accuracy
The accuracy of detecting of DR
Time frame: Baseline-Month 12
The percent of invalid images
The percent of invalid images for analysing by neural network
Time frame: Baseline-Month 12
The percent of false positive detection of DR
The percent of false positive detection of DR in individuals without DR
Time frame: Baseline-Month 12
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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The Filatov Institute of Eye Diseases and Tissue Therapy