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  • FDA approves topography-guided LASIK

    Alcon
    Refractive Mgmt/Intervention
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    Alcon announced that the FDA has approved topography-guided custom ablation LASIK procedures for the company’s WaveLight Allegretto Wave Eye-Q Excimer Laser.

    Alcon’s is the first topography-guided treatment to receive FDA approval. The treatment incorporates refractive error and corneal irregularities into custom laser ablation for myopia and myopic astigmatism.

    In addition to wavefront-guided and wavefront-optimizedtreatments, WaveLightcan perform individualized ablations based on the unique topography of patients’ eyes.

    Alcon is developing educational materials to support the rollout of this technology. Initial clinical use is planned to take place at a small number of experienced sites before wider commercial launch later in 2014.

    The FDA approval was based on a multi-center phase III study using the Allegretto Wave Eye-Q Excimer Laser System for the treatment of manifest and cornea-based myopic optical errors. The study demonstrated that:

    • 92.7 percent of all study eyes achieved a UCVA of 20/20 or better, and 68.8 percent of all eyes achieved a UCVA of 20/16 three months after surgery;
    • 29.6 percent of eyes gained at least one line of BSCVA three months after surgery;
    • Symptoms traditionally associated with LASIK, such as glare, halos, difficulty driving at night, light sensitivity and eye dryness, improved after topography-guided LASIK treatment with the laser system, and;
    • Visual symptoms after topography-guided LASIK were generally mild in severity and continued to improve with time; none of the visual symptoms were rated as “marked” or “severe” at three months or later post-surgery.

    “Topography-guided LASIK is an invaluable tool in our refractive armamentarium, allowing us to accurately measure corneal topography and address corneal irregularities as part of the individualized laser treatment,” said R. Doyle Stulting, MD, PhD, director of the Stulting Research Center, emeritis professor of ophthalmology at Emory University and adjunct professor of ophthalmology at Moran Eye Center. “Study results were impressive, not only for visual acuity and refractive accuracy, but also for the reduction in visual symptoms typically associated with other treatments.”