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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857943
• Other study ID #: AEYE-DS-002
• Status: Completed
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: AEYE Health LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: October 10, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Karas Health Care	Fayetteville	Arkansas
United States	The Jackson Clinic	Jackson	Tennessee
United States	Lake Nona Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AEYE Health LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity		1 year