Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images

Inclusion criteria

• Male or female, Age≥22
• Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):

• Elevated Hemoglobin A1c (HbA1c) ≥ 6.5% (48mmol/mol), based on repeated assessments, performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay OR
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), based on repeated assessments, where 'fasting' is defined as no caloric intake for at least 8 hours OR
• 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 OR
• Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dl (11.1 mmol/L)
• Understand the study and volunteer to sign the informed consent

Exclusion criteria

• Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
• Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
• Previously diagnosed with Diabetic Retinopathy.
• History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
• Currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
• Subject 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).
• Subject is contraindicated for imaging by fundus imaging systems used in the study:

• Subject is hypersensitive to light
• Subject recently underwent photodynamic therapy (PDT)
• Subject is taking medication that causes photosensitivity
• Subject has a history of angle-closure glaucoma or narrow anterior chamber angles
• Subject is pregnant