RETeval Study for Diabetic Retinopathy

Completed · Not applicable

Conditions studied: Diabetic Retinopathy

In brief

RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field, dilated, stereo, color fundus photography, read according to the ETDRS protocol, will be used as the gold standard.

Key facts

Study ID

NCT01950663

Run by

Inoveon Corporation

People needed

468

Starts

2013-09-01

Expected to finish

2014-04-01

Last updated by the study team

2017-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with diabetes and treated with at least one oral hypoglycemic medication or insulin
• Eighteen years or older

You may not qualify if…

• History of photosensitive epilepsy
• Previous laser or drug treatment for diabetic retinopathy or macular edema
• Eye diseases other than diabetic retinopathy or macular edema that, in the opinion of the recruiting ophthalmologist, may affect the electroretinogram or result in ungradable Early Treatment Diabetic Retinopathy Study Protocol images.
• Inability or unwillingness of the subject or legal guardian/representative to give written informed consent

Where it is running

• Atlanta VA Medical Center — Decatur, Georgia, United States
• Oklahoma City VA Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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