Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.
• Ability to sign and date the informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Age (≥)21 years of age or older
• Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)
‣ Hemoglobin A1c (HbA1c) ≥ 6.5%
⁃ Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
⁃ Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)