Anamed Inc announced that the U.S. Food and Drug Administration (FDA) approved the expansion of the clinical trial with its PermaVision intracorneal lens for the correction of hyperopia (farsightedness) up to + 6 diopters. The company earlier announced that all patients authorized for Phase I of this study had been enrolled and that the U.S. National Institute of Health (NIH) had awarded the Company a $1.44 million Phase II Small Business Innovative Research grant to help fund its US clinical trials.
"The PermaVision lens is designed to offer an outstanding solution to hyperopia, especially in the higher ranges. The lens also offers the advantage of being removable, an important option in today's refractive surgery environment," said Dr. Stephen G. Slade, director of The Laser Center of Houston. "Now that we have better microkeratomes and what seems to be a very compatible artificial material, I think we are well on the path to making keratophakia a powerful alternative to current tissue removal vision correction procedures."
The PermaVision intracorneal lens is implanted in a sutureless surgical procedure. A flap is created in the cornea (just like in LASIK), the micron-precisioned lens is placed under the flap and centered over the pupil. The flap is then folded back over the lens and the eye. Fluid dynamics keeps the lens and the flap in place. No stitches are necessary. Unlike LASIK, which removes tissue, this procedure is additive, allowing the lens to be removed or exchanged.