Assessment of EyeArt Performance With Retinal Imaging Devices

Assessment of EyeArt Performance With Retinal Imaging Devices

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

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.