Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy

In by alicia.green

Locations
Jacksonville (Headquarters)
Condition
Diabetes, Eye Disease

Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy

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Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. 22 years of age or older
  2. Documented diagnosis of diabetes mellitus, as per any of the following:
    1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
    2. Hemoglobin A1c (HbA1c) ≥ 6.5%
    3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
    4. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
    5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
  3. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
  1. Currently participating in an interventional eye study
  2. Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
  3. Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation)
  4. Pregnancy
  5. Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
  6. History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
  7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
  8. Any condition that is contraindicated for the use of the study camera
  9. Contraindication for imaging by devices used in the study due to any of the following:
    1. Subject is hypersensitive to light
    2. Subject recently underwent photodynamic therapy (PDT)
    3. Subject is taking medication that causes photosensitivity
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