A rigorous multi-center clinical trial has completed testing over 400 diabetic patients to evaluate the effectiveness of RETeval® based visual electrophysiology in assessing sight threatening diabetic retinopathy in comparison to the gold standard of dilated seven field stereo fundus photography, double read and adjudicated.
Diabetic Retinopathy is defined as damage to the retina that has come about as a direct consequence of high levels of blood glucose. The delicate network of blood vessels that supplies the retina is sensitive to blood glucose, pressure and fat content, all of which makes monitoring its condition an important component in maintaining patient’s ocular health.
RETeva® is a handheld Diabetic Retinopathy(DR) screening device that enables any health care provider to screen a diabetic for sight-threatening DR in less than three minutes with no need for dilation, regardless of pupil size or the presence of cataracts. The device is CE marked and approved in Canada, Australia and Japan. It is in use in the U.K., India, Canada, Malaysia, and Japan.
The RETeval® clinical trial Primary Investigator is Stephen R. Fransen, Associate Professor at the Dean McGee Eye Institute, University of Oklahoma and Chief Medical Officer of Inoveon, a provider of ETDRS 7-field stereo fundus photography services.
The company will be showing its wares and no doubt presenting clinical results during the forthcoming ARVO (Association for Research in Vision and Ophthalmology) Annual Meeting in Orlando, Florida, May 4-7.
LKC has also announced a new RETeval® option allowing RETeval® to be a full function, hand-held, flash ERG/VEP device that will run the complete five and/or six step ISCEV flash ERG protocol using skin electrodes.
According to LKC Technologies President James J. Datovech, “The preliminary results are excellent. The medical, diabetic care and public health communities will find great value in this technology.” “This brings DR screening to wherever diabetics meet their care, enabling them to refer at risk diabetics to ophthalmologists that manage diabetic retinopathy and CSME.” He continued, “Using skin electrodes (not corneal electrodes) and a simple handheld device, minimizes the cost and complexity of the DR screening equation.”
Source: LKC Technologies, Inc., PR Newswire