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SOURCE LKC Technologies, Inc.
GAITHERSBURG, Md., June 16, 2014 /PRNewswire/ -- The 74th Scientific Session of the American Diabetes Association (ADA) was the setting that released the initial results from the recently completed 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).
Data from the RETeval clinical trial, involving over 400 diabetic patients at two VA Hospital Centers, was discussed in a poster presentation at ADA's prestigious Scientific Sessions at San Francisco's Moscone Center on June 15.
A major issue with imaging techniques for diabetic eye disease screening is the high imaging technical failure rate due to either small pupil size or corneal issues such as cataracts. This poster reviewed the study results that compared the technical failure rate of RETeval to ETDRS dilated 7-field stereo fundus photography. April Maa, MD, the Principal Investigator at the Atlanta Veterans Administration Hospital study site, presented this poster.
RETeval is a handheld DR screening device utilizing skin electrodes (not corneal electrodes) that enables virtually any health care provider to screen for sight-threatening DR in just a few minutes per patient. No dilation is required regardless of pupil size or the presence of a cataract.
"We are very pleased by the findings from this trial," said LKC Technologies President James Datovech. "The data is both exciting and important to the medical, diabetic care and public health communities as it further validates RETeval as a fast, efficient, cost effective and easy to use device that compares well to the gold standard in screening for DR."
"The clinical trial results represent a major breakthrough in making the need for universal DR screening a reality," Datovech said. "We now have the ability to effectively and affordably bring DR screening to wherever diabetics seek care and enabling their care providers to refer at-risk diabetics to ophthalmologists who manage diabetic retinopathy and CSME."
LKC company representatives also plan to exhibit the RETeval device at the International Bio Meeting, June 23-25 in San Diego, the Euretina/ESCRS meeting, September 12-16 in London and the American Academy of Ophthalmology (AAO) meeting October 18-25 in Chicago.
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