Assessment of Retinal Fundus Imaging Camera

Inclusion Criteria:

• 22 years of age or older.
• Documented diagnosis of diabetes mellitus, as per any of the following: Having met thecriteria established by the World Health Organization (WHO) and/or the AmericanDiabetes 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-hourplasma 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 orhyperglycemic 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 DMEor 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.

Exclusion Criteria:

• Currently participating in an interventional eye study (e.g., actively receiving theinvestigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).
• Has a condition that, in the opinion of the investigator, would preclude participationin the study (e.g., unstable medical status including blood pressure or glycemiccontrol, microphthalmia, or previous enucleation).
• Pregnancy
• Has a known allergy to or contraindication for the use of Tropicamide 1% or othermydriatic eye drops.
• Any condition that is contraindicated for the use of study devices in the opinion ofthe 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