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

Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (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:

• 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.

• 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