Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
1 other identifier
interventional
531
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2020
CompletedFirst Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2021
CompletedResults Posted
Study results publicly available
August 1, 2023
CompletedAugust 1, 2023
May 1, 2023
1.1 years
October 28, 2020
May 23, 2023
July 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
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.
1 day
Secondary Outcomes (3)
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
Study Arms (1)
AEYE Software Device
EXPERIMENTALAn 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.
Interventions
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 Optical Coherence Tomography (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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AEYE Health Inclead
Study Sites (1)
The Eye Care Institute
Louisville, Kentucky, 40206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zack Dvey-Aharon, PhD
- Organization
- AEYE Health Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 3, 2020
Study Start
October 16, 2020
Primary Completion
November 28, 2021
Study Completion
December 26, 2021
Last Updated
August 1, 2023
Results First Posted
August 1, 2023
Record last verified: 2023-05