Assessment of Retinal Fundus Imaging Camera

Eligibility Criteria

• * 22 years of age or older.
• * Documented diagnosis of diabetes mellitus, as per any of the following: Having met the criteria established by the World Health Organization (WHO) and/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 75g 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.
• * Diagnosis from a retinal specialist of ETDRS level of 35 or higher with or without DME or diagnosis from a retinal specialist of ETDRS level 20 or lower and no DME.
• * Standard Corrected Visual Acuity of at least 20/40 or better in both eyes.
• * Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).
• * Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation).
• * Pregnancy
• * Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops.
• * Any condition that is contraindicated for the use of study devices in the opinion of the investigator.
• * 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