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Coastal Vision Participates in First USA FDA Trial of the VisAbility Implant System

Coastal Vision Participates in First USA FDA Trial of the VisAbility Implant System

Created on: Wednesday, January 06, 2016
Author: Coastal Vision Medical Group

Orange, CA – September 29, 2015 – Dr. Dan B. Tran of Coastal Vision Medical Group today announced the commencement of a United States FDA Clinical Trial for the VisAbility™ Implant System (VIS) (Refocus Group, Inc.) for the treatment of presbyopia. The trial is being conducted to determine if this new presbyopia-correcting procedure will be able to reduce or eliminate the need for reading glasses or contact lenses worn to correct presbyopia or the loss of near vision. The VIS is currently approved in Europe and current U.S. trials are being conducted in preparation for a future U.S. approval and worldwide launch.

The VisAbility™ Procedure is the world’s first and only binocular solution (meaning that it is for both eyes) that works outside of the visual axis (line of sight) to correct age-related near vision loss, called presbyopia. It works by restoring the natural ability of the focusing muscle inside the eye. By restoring this ability, the VIS offers patients the benefit a full range of focus without compromise to distance vision and a reduced need for corrective eyeglasses. In earlier trials, the VIS Procedure demonstrated an outstanding safety profile. Additionally, the VisAbility™ Implants used in the procedure are removable. 

Existing treatment options for presbyopia offer only monovision, bifocal, or multifocal solutions and compromise the full range of focus. These treatment options are also either cornea- or lens-related, and work within the visual axis but do not restore the natural focusing ability. Treatment options that remove corneal tissue can limit and/or compromise future vision procedures.

Dr. Tran is excited to be a part of the VisAbility™ trial and to be able to offer patients this new procedure. VisAbility™ is the latest technology in presbyopia correction and works in a brand new way to correct the problem. It offers patients the chance to see better up close without compromising their ability to see at a distance and may even help them get rid of their reading glasses altogether. It could be a real breakthrough in how presbyopia is treated.

Recruitment efforts to enroll trial participants are currently underway. To qualify, patients must meet the following criteria:

  • Be between 45 and 60 years of age
  • Have difficulty focusing on close objects
  • Do not need glasses or contacts to see objects that are far away
  • Have not had prior eye surgery
  • Have not been diagnosed with any major medical conditions
  • Live within one hour of the study clinic

Participation in the trial includes study related exams and medication at no cost and compensation for time and travel. Interested persons should contact study coordinator Ashley Owyang, OD at ashleyowyang@coastal-vision.com for more information about trial eligibility and enrollment.

About Coastal Vision Medical Group: Coastal Vision Medical Group is a premier Orange County eye care provider, established in 1999. Our surgeons are highly trained and experienced in LASIK vision correction, Cataract Surgery and treating Glaucoma. Our mission is to provide the best possible medical and surgical ophthalmological care for our patients utilizing the latest technology available, both internally or elsewhere.

About Refocus Group: Refocus Group, Inc. is a medical device company engaged in the research and development of treatments for human vision disorders. The company has a mission to become the worldwide surgical standard of care for presbyopia. Their latest technology — the VisAbility Implant System (VIS) — is designed to ensure dramatically improved and more consistent long-term outcomes than previous products through a fully secure implant design and a more precise and standardized procedure. This correction is accomplished by a systematic, minimally-invasive outpatient procedure that involves implantation of biocompatible VisAbility Implants. The VIS procedure restores the natural ability to focus and provides effective binocular improvement of near and intermediate vision, without compromise to distance vision. Refocus Group’s products hold the CE Mark and are approved for sale in the European Union. Refocus Group is currently conducting a post-market multi-center study for the treatment of presbyopia in key centers throughout the European Union, and an IDE clinical trial in the United States.

For further information on Refocus Group and the VisAbility Implant System, please visit www.refocus-group.com or email info@refocus-group.com.



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