ReVision Optics (RVO) focused on the research, development and manufacturing of custom optical products to correct and maintain vision, has begun its US clinical trial of the PresbyLens corneal inlay for restoration of near vision.
RVO said that the PresbyLens is an investigational device and is limited by US federal law to investigational use only. The clinical trial will evaluate the PresbyLens corneal inlay for the correction of presbyopia, the age-related loss of near vision.
The study began on April 6th with the treatment of three subjects by clinical investigator Dr Stephen Slade of the Slade & Baker Vision Center in Houston, Texas.
The PresbyLens clinical study will evaluate 400 presbyopic subjects for three years. During the initial phase of enrollment, 30 eyes will be treated at two clinical sites. The first two investigators chosen are Dr Stephen Slade and Dr Jon Dishler of the Dishler Laser Institute in Greenwood Village, Colorado.
RVO’s PresbyLens inlay is a patented refractive surgery solution. The inlay is designed to improve the near vision that has been lost by the eye’s natural aging process called presbyopia. The PresbyLens inlay is removable, and provides an ideally suited surgical option for near and intermediate vision enhancement.
ReVision Optics said that it is actively pursuing regulatory approvals and market opportunities for the PresbyLens worldwide. The PresbyLens has its CE mark and is approved for sale in Europe.
ReVision Optics claimed that the PresbyLens has the potential to gently reshape the cornea to improve a patient’s near or reading vision. The lens is made from a proprietary, optically clear, biocompatible material that is similar to the material used in a soft contact lens.
Randy Alexander, president and CEO of ReVision Optics, said: “We are pleased to begin our US clinical trials for the PresbyLens. Our research and development studies strongly indicate that we may be able to provide a solution for one of the most common vision issues, presbyopia.”