Assessment of EyeArt Performance With Retinal Imaging Devices

Completed

Conditions studied: Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT04302012

Run by

Eyenuk, Inc.

People needed

62

Starts

2019-12-18

Expected to finish

2020-02-27

Last updated by the study team

2021-07-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Lundquist Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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