Assessment of EyeArt Performance With Retinal Imaging Devices

Eyenuk

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Procedure: Color fundus photography; Drug: Mydriatic Agent

Study type: Observational

Funder types: Industry

Identifiers

NCT04302012

EN-01a

Details and patient eligibility

About

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

Enrollment: 62 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 macular edema, severe non-proliferative retinopathy, proliferative retinopathy, or 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.