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

NCT ID: NCT05857943

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2023-10-10

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.

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AEYE-DS Software

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AEYE Health Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Karas Health Care

Fayetteville, Arkansas, United States

Lake Nona Research

Orlando, Florida, United States

The Jackson Clinic

Jackson, Tennessee, United States

Countries

United States

Other Identifiers

AEYE-DS-002

Identifier Type: -

Identifier Source: org_study_id