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LKC Technologies' Clinical Trial Validates Cost-Effective Alternative to Gold Standard in Diabetic Retinopathy Screening. Details to be presented at EURETINA/ESCRS London


News provided by

LKC Technologies, Inc.

04 Sep, 2014, 10:00 GMT

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GAITHERSBURG, Maryland, Sept. 4, 2014 /PRNewswire/ -- The EURETINA/ESCRS joint congress scheduled for 12-16 September is the setting for April Maa, MD, Primary Investigator, to present results from a multi-center diabetic retinopathy (DR) screening clinical trial. The trial evaluated the effectiveness of RETeval™ based visual electrophysiology in assessing sight-threatening DR as well as clinically significant macular edema (CSME) in comparison to the gold standard of dilated seven-field stereo fundus photography (double read and adjudicated).

The results from a 467 diabetic patient trial at two U.S. Veterans Affairs (VA) Hospital Centers will be presented on Saturday, 13 September at 16.30 at the Free Paper Session #14 "Vascular Diseases and Diabetic Retinopathy IV "in Boulevard F on Level 1 of the meeting venue.  The device can be seen at the LKC exhibit stand B45 during the entire meeting in London.

High imaging technical failure rates are a major issue with fundus photography, especially without dilation. This presentation will compare the technical failure rate of non-mydriatic RETeval as compared to dilated ETDRS 7-field stereo fundus photography.  Other study results, including sensitivity and specificity, will also be presented. 

The data validates RETeval as a fast, efficient, cost effective and easy-to-use device whose performance compares well to the gold standard in the screening of diabetics for eye disease with a technical failure rate of <1%. 

RETeval, a handheld electrophysiology based functional screening device, utilizes skin electrodes (not corneal electrodes).  It enables virtually any health care provider to screen for sight-threatening DR and CSME in just a few minutes per patient without dilation regardless of pupil size or the presence of a cataract providing immediate results.

Datovech said, "We are delighted to  bring this cost-effective DR screening capability to diabetics wherever they seek care.  We can enable care providers to refer at-risk diabetics to ophthalmologists who manage  diabetic retinopathy and CSME.  The medical, diabetic care and public health communities will find great value in this technology." 

The RETeval is available for sale and clinical use in Japan, Australia, Canada and the European Union under CE mark.

A RETeval poster presentation is scheduled at the American Academy of Ophthalmology (AAO) meeting in Chicago and LKC will exhibit the RETeval during the AAO meeting - 18-25 October, 2014.

RETeval information can be found at www.LKC.com

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