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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04612868
Recruitment Status : Completed
First Posted : November 3, 2020
Last Update Posted : March 17, 2022
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE October 28, 2020
First Posted Date  ICMJE November 3, 2020
Last Update Posted Date March 17, 2022
Actual Study Start Date  ICMJE October 16, 2020
Actual Primary Completion Date November 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
Performance of the AEYE-DS software for the detection of more than mild diabetic retinopathy (mtmDR) on digital funduscopic images from patients with known diabetes. [ Time Frame: 1 day ]
sensitivity and specificity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Official Title  ICMJE Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetic Retinopathy
Intervention  ICMJE Device: AEYE Software Device

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.
Study Arms  ICMJE Experimental: AEYE 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.
Intervention: Device: AEYE Software Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2022)
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2020)
Actual Study Completion Date  ICMJE December 26, 2021
Actual Primary Completion Date November 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 DR or 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04612868
Other Study ID Numbers  ICMJE AEYE-DS-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party AEYE Health LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AEYE Health LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AEYE Health LLC
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP