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

Prospective Clinical Trial to Demonstrate the Efficacy and Safety if AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images Obtained With a Funduscopic Device

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.

Inclusion Criteria:

1. Age ≥22
2. Male or female
3. Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
4. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

1. Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.

2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.

3. Previously diagnosed with Diabetic Retinopathy.

4. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.

5. Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.

6. 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).

7. 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

8. Subject is pregnant.