Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images

Inclusion criteria

• Age ≥22
• Male or female
• Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
• 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 DME.
• Participant 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).
• Participant is contraindicated for imaging by fundus imaging systems used in the study:

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