Alcon Inc announced that the U.S. Food and Drug Administration (FDA) Ophthalmic Devices Panel unanimously recommended approval of its customized wavefront-guided laser eye surgery application for myopia between 0 and -7 diopters.
Utilizing the LADARVision 4000 excimer laser and the LADARWave wavefront measuring device, Alcon brings a system approach to custom laser eye surgery. High and low order aberrations unique to each patient eye are captured by the LADARWave aberrometer. This information is then transferred to the LADARVision 4000 excimer laser where it is electronically registered and computer matched to create the precision ablation required in customized laser eye surgery.
"Unlike current laser modalities for correcting refractive errors, wavefront guided customized LASIK should provide surgeons the ability to control the visual effects of higher-order aberrations. Treating aberrations, which impact low contrast visual activities such as night driving, should improve the patient's quality of vision," said Dr. Stephen Brint, Associate Professor of Ophthalmology at Tulane University School of Medicine and one of the five surgeons participating in the clinical investigations.
"The refractive community has eagerly anticipated this new technology," said Bill Barton, VP and General Manager, Surgical Division. "We are proud to be the first in the industry to offer an approach that has the potential to improve visual acuity and enhance overall vision quality as compared to today's conventional LASIK Surgery. We will work proactively with the FDA to address the labeling recommendations set forth by the Panel."
Alcon was the first company to initiate FDA clinical trials for customized LASIK surgery using a wavefront measurement device and an excimer laser. Clinical trials are continuing for the treatment of myopic astigmatism, hyperopia with and without astigmatism and other ocular irregularities utilizing this technology.