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

NACompletedINTERVENTIONAL
Enrollment

531

Participants

Timeline

Start Date

October 16, 2020

Primary Completion Date

November 28, 2021

Study Completion Date

December 26, 2021

Conditions
Diabetes MellitusDiabetic Retinopathy
Interventions
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 Optical Coherence Tomography (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 (1)

40206

The Eye Care Institute, Louisville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AEYE Health Inc

INDUSTRY