Camera Qualification Study

A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.

Inclusion criteria

• 22 years of age or older
• Documented diagnosis of diabetes mellitus, as per any of the following:

• Having met the criteria established by either 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)
• 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
• Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Currently participating in an interventional eye study
• Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
• 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)
• Pregnancy
• Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
• History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
• Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
• Any condition that is contraindicated for the use of the study camera
• Contraindication for imaging by devices used in the study due to any of the following:

• Subject is hypersensitive to light
• Subject recently underwent photodynamic therapy (PDT)
• Subject is taking medication that causes photosensitivity