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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT04612868

Run by

AEYE Health Inc

People needed

531

Starts

2020-10-16

Expected to finish

2021-12-26

Last updated by the study team

2023-08-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• 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

Where it is running

• The Eye Care Institute — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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