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

AEYE Health LLC (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: AEYE-DS Software

Study Design

Study Type:
Anticipated Enrollment :
369 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
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
Actual Study Start Date :
Mar 29, 2023
Anticipated Primary Completion Date :
Dec 29, 2023
Anticipated Study Completion Date :
Mar 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AEYE-DS Software Device

An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy

Device: AEYE-DS Software
Eligible participants will undergo the following procedures: Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis. -Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis. -All study subjects will have their pupils dilated using dilation drops.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and Specificity [1 year]

Eligibility Criteria


Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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):
  1. 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:

  8. Participant is hypersensitive to light

  9. Participant recently underwent photodynamic therapy (PDT)

  10. Participant is taking medication that causes photosensitivity

  11. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles

  12. Subject is pregnant.

Contacts and Locations


Site City State Country Postal Code
1 Karas Health Care Fayetteville Arkansas United States 72701
2 Lake Nona Research Orlando Florida United States 32832
3 The Jackson Clinic Jackson Tennessee United States 38305

Sponsors and Collaborators

  • AEYE Health LLC


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • AEYE-DS-002
First Posted:
May 15, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 15, 2023