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

November 7, 2023 updated by: AEYE Health LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • Karas Health Care
    • Florida
      • Orlando, Florida, United States, 32832
        • Lake Nona Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEYE Health LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEYE-DS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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