A Medical Device Daily
Advanced Medical Optics (AMO; Santa Ana, California), a developer of ophthalmic surgical devices and eye care products, said that the FDA has approved the Advanced CustomVue Monovision procedure, which it said is the first wavefront-guided laser vision correction procedure for the visual correction of myopic (nearsighted) presbyopic patients, with and without astigmatism.
Presbyopia is part of the natural aging process and affects most people sometime in their 40s. The condition causes the lens of the eye to lose flexibility, gradually diminishing its ability to focus on objects up-close.
The Advanced CustomVue Monovision procedure is individualized for the correction requirements of presbyopic patients with low to moderate myopia and astigmatism and is the only FDA-approved monovision treatment performed with an excimer laser.
The treatment can improve both near and distance vision using AMO's Lasik technologies, including the Star S4 IR excimer laser and the WaveScan Wavefront and Iris Registration technologies, to first map, and then custom-correct nearsightedness in the dominant eye, and partially correct nearsightedness in the other eye. The procedure is individualized for the unique correction requirements of presbyopic patients with low to moderate myopia, with and without astigmatism. The result is a reduced dependency on reading glasses and contact lenses.
"This approval marks another industry first for AMO," said Jim Mazzo, AMO president/CEO and chairman. "The Advanced CustomVue Monovision procedure is the only FDA-approved wavefront-guided Lasik treatment for the correction of both near and distance vision of presbyopic patients."