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

NACompletedINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

September 11, 2023

Study Completion Date

October 10, 2023

Conditions
Diabetes MellitusDiabetic Retinopathy
Interventions
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.

Trial Locations (3)

32832

Lake Nona Research, Orlando

38305

The Jackson Clinic, Jackson

72701

Karas Health Care, Fayetteville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AEYE Health Inc

INDUSTRY