PowerVision has announced that six-month data from the pilot study of the FluidVision lens confirmed the lens' ability to restore vision at all distances.
Results were presented by principal investigator Dr Paul Roux of the Optimed Eye and Laser Clinic in Pretoria, South Africa at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Symposium, which concludes here on 28 April 2014.
The FluidVision lens provides True Accommodation by mimicking the eye’s natural accommodative process to change shape and adjust focus the way that young, healthy eyes do. The lens is implanted using the same surgical techniques as are used with traditional intraocular lenses.
The pilot study included 20 patients who were candidates for cataract surgery and underwent implantation of the FluidVision lens in one eye. Initial results showed excellent distance vision, averaging better than 20/20 at six-month follow-up.
Visual acuities at intermediate and near were also impressive at six months, approximately 20/25 and 20/33 respectively, when tested in one eye, and allowed patients to read without glasses. The visual outcomes provided by the lens should improve even more in patients when they have lenses implanted in both eyes. The study also confirmed the safety of the lens, with no clinical complications or adverse events reported.
PowerVision president and CEO Barry Cheskin noted that the company is extremely pleased with the outcome of its pilot study and look forward to confirming these results in its ongoing CE Mark study.
"Seven sites in Germany and South Africa are enrolling patients, and nineteen patients have been implanted to date. We expect to complete patient enrollment this year and to receive the CE Mark sometime in 2015. This study will lay the groundwork for potential commercialization in the EU and further studies in the United States," Cheskin added.
Separate studies presented at the symposium highlighted the FluidVision lens’ unique delivery system, PowerJect, which allows physicians to easily prepare the lens for implantation and then implant it, and also demonstrated that the lens capsule is remarkably stable over time after implantation of the lens.