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

Sponsor

AEYE Health LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT04612868

Collaborator

(none)

531

Enrollment

Location

Arm

14.3

Actual Duration (Months)

37.1

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Diabetic Retinopathy	Device: AEYE Software Device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

531 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images

Actual Study Start Date :

Oct 16, 2020

Actual Primary Completion Date :

Nov 28, 2021

Actual Study Completion Date :

Dec 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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. [1 day]
sensitivity and specificity

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Eye Care Institute	Louisville	Kentucky	United States	40206

Sponsors and Collaborators

AEYE Health LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AEYE Health LLC

ClinicalTrials.gov Identifier:

NCT04612868

Other Study ID Numbers:

AEYE-DS-001

First Posted:

Nov 3, 2020

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Mar 17, 2022