Assessment of EyeArt Performance With Retinal Cameras

Eyenuk

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Drug: Mydriatic Agent; Procedure: Retinal imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT04984200

EN-01b

Details and patient eligibility

About

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

Enrollment: 246 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of diabetes mellitus;
• Understanding of study and provision of written informed consent; and
• 22 years of age or older.

Exclusion criteria

• 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.

Trial design

246 participants in 1 patient group

AB

Treatment:

Drug: Mydriatic Agent

Procedure: Retinal imaging