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

Sponsor

AEYE Health LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05857943

Collaborator

(none)

369

Enrollment

Locations

Arm

Anticipated Duration (Months)

123

Patients Per Site

10.2

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 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
Diabetes Mellitus Diabetic Retinopathy	Device: AEYE-DS Software	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

369 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

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

Sensitivity and Specificity [1 year]

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.
Previously diagnosed with Diabetic Retinopathy.
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
Subject is pregnant.

Contacts and Locations

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AEYE Health LLC

ClinicalTrials.gov Identifier:

NCT05857943

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:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of May 15, 2023