Assessment of EyeArt Performance With Retinal Cameras

Eyenuk, Inc.1 site in 1 country246 target enrollmentJuly 13, 2021

Overview

Phase: Not Applicable
Intervention: Retinal imaging
Conditions: Diabetic Retinopathy
Sponsor: Eyenuk, Inc.
Enrollment: 246
Locations: 1
Primary Endpoint: Overall agreement between the results from multiple EyeArt operations
Status: Completed
Last Updated: 3 years ago

The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.

Registry

clinicaltrials.gov

Start Date

July 13, 2021

End Date

August 19, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Persistent visual impairment in one or both eyes;
•History of retinal vascular (vein or artery) occlusion;
•History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
•Subject is contraindicated for fundus photography (for example, has light sensitivity);
•Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
•Subject is currently enrolled in an interventional study of an investigational device or drug; or
•Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.