PowerVision, Inc., a medical device company developing the world's first fluid-based accommodating intraocular lens, today announced that the first 10 patients have received lens implants in its multi-center clinical study assessing the performance of the lens in cataract patients. These patients received their implants at the three eye centers in South Africa that are participating in the study; four sites in Germany are also participating in the study and will begin enrolling patients later in 2014. The planned enrollment in this study is 115 participants undergoing cataract surgery. This study will form the basis for PowerVision's CE marking of the FluidVision lens in the European Union, which is expected to occur sometime next year.
"As we age, the natural lens begins to stiffen and loses its ability to change shape which makes it more difficult to read and focus at near. As a result, millions of adults over age 50 require glasses for reading and near work. Also, millions more patients have cataracts, which further impairs their vision," said Prof. Dr. med. Gerd U. Auffarth, Principal Investigator. "Current treatment options that restore both near and far vision are limited. Results from an earlier pilot study of the FluidVision lens are quite encouraging, and we believe patients will benefit significantly from this lens which has the potential to restore the eye's ability to focus clearly on objects near, far and in between."
Accommodation refers to the eye's ability to dynamically adjust focus to see up close and at a distance. The FluidVision lens, PowerVision's novel fluid-controlled accommodating intraocular lens, contains fluid inside the lens that moves in response to the natural muscle forces in the eye. The FluidVision lens provides True Accommodation™ by mimicking the eye's natural accommodative process, becoming thicker when the patient needs to see up close or thinner when he or she needs to see far away.
"We are deeply grateful to all of our clinical investigators for their involvement and interest in this groundbreaking study. We expect to complete patient enrollment this year and to receive the CE Mark sometime in 2015," said PowerVision's President & CEO, Barry Cheskin. "Many millions of people around the world are impacted by cataracts and presbyopia and we believe there is a significant unmet need for more effective treatments of these clinical conditions."
Participating South African sites in the current study are:
John Hill Eye Laser Centre in Claremont, Cape Town under direction of Principal Investigator, John Hill, M.D.
Visiomed Laser Centre in Northcliff, Johannesburg under direction of Principal Investigator, Michael A Muller, M.B. ChB
Optimed Eye and Laser Centre in Queenswood, Pretoria under direction of Principal Investigators Frik J Potgieter, M.B. Ch.B and Paul Roux, M.D.
Participating German sites are:
Department of Ophthalmology Ruprecht-Karls University Heidelberg, Heidelberg, Baden-Wurttemberg, under the direction of Principal Investigator Gerd F. Auffarth, M.D.
Charlottenklinik fuer Augenheilkunde, Stuttgart, Baden-Wurttemberg, under the direction of Principal Investigator Gangolf Sauder, M.D.
Center for Vision Science Ruhr University Eye Hospital, Bochum, North Rhine-Westphalia, under the direction of Principal Investigator Burkhard Dick, M.D.
Augentagesklinik, Berlin, under the direction of Principal Investigator Manfred Tetz, M.D.
Source: PowerVision, Inc.