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Largest Retrospective Study Shows Positive Results for Stroke and TBI Patients Treated With VRT™

04/07/2006

04/07/2006 » SAN DIEGO, CALIF. — Yesterday researchers at the American Academy of Neurology 58th Annual Meeting reported positive results from the largest retrospective study conducted to date of stroke and brain trauma patients seeking improvement of their vision impairment with NovaVision™ VRT™ Vision Restoration Therapy™.

"Restoring Visual Function after Brain Injury: A Large-Sample Retrospective Study Using Vision Restoration Therapy™ (VRT™)," was presented by Bernhard A. Sabel, Ph.D., Professor and Chair of Medical Psychology at University of Magdeburg in Germany. Research was conducted in collaboration with Iris Mueller, also of University of Magdeburg Institute of Medical Psychology. In the study, 302 patients with stroke- and brain trauma-related visual field deficits completed a six month regimen of daily VRT™ therapy. Key results presented by Professor Sabel to meeting attendees are as follows:

• 70.9% of patients exhibited moderate or dramatic visual field improvement.
• The average improvement of visual field was 5°.
• The findings emphasized the clinical relevance of neuroplasticity of the visual system and confirms that VRT™ is an effective home-based rehabilitation method for restoring visual function caused by stroke or traumatic brain injury.

"This large-sample trial reinforces the finding of previous small-sample studies, like the 1998 study published in Nature Medicine—VRT™ is an effective therapy to improve vision deficits caused by stroke and brain trauma," Professor Sabel said. "For example, improving the visual field by 5 degrees enables patients to regain the capability to read or watch television, among other hobbies." Bernhard Sabel is also a member of the Scientific and Medical Advisory Board of NovaVision™, Inc., and developed VRT™ based on over 15 years of clinic research.

VRT™ is based on the principle of neuroplasticity—the ability of the brain to repair itself to compensate for injury. NovaVision™ VRT™ was cleared by the U.S. Food and Drug Administration (FDA) in April 2003. The average therapy regimen takes six months, and involves brief daily sessions of interaction with a clinically configured field of visual stimuli on a VRT™ medical device patients use at home.

Second Study Reports Stability of Visual Field Improvements

Another study by doctors Sabel and Mueller, "Stability of Visual Field Improvements 3.8 Years after Discontinuing Vision Restoration Therapy™ (VRT™)," was presented in a poster session earlier in the week. The study monitored 24 patients who previously conducted VRT™ for six or 12 months and demonstrated an improvement in visual field. The data demonstrates VRT™ lead to visual field size increases that were stabile over a period of at least 3.8 years. This stability was irrespective of whether patients previously conducted VRT™ for six or 12 months suggesting that restored sectors of the visual fields are maintained and used in every day vision.

The need for a rehabilitative therapy like VRT™ is substantial—approximately 1.5 million stroke and TBI patients in the United States suffer from major visual field deficits, and that number grows by more than 90,000 new patients each year.

"These studies provide further evidence to support clinical applications of neuroplasticity including VRT™. It was previously believed visual field loss in stroke and TBI patients could not be improved, but clinical data on the efficacy of VRT™ continue to prove the contrary," said NovaVision™ President and CEO Navroze Mehta. "Like speech, physical and occupational therapies, VRT™ has emerged as a new pillar of therapy that substantially improves the quality of life for these patients."