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

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.
• •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 Diabetic Retinopathy (DR) or Diabetic Macular Edema (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:
• •1. Participant is hypersensitive to light
• •2. Participant recently underwent photodynamic therapy (PDT)
• •3. Participant is taking medication that causes photosensitivity
• •4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles