Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AEYE Health Inc
- Enrollment
- 531
- Locations
- 2
- Primary Endpoint
- Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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
Outcomes
Primary Outcomes
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Time Frame: 1 day
Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
Secondary Outcomes
- Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)(1 day)
- Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)(1 day)
- Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)(1 day)