FDA Approves Bifocal LASIK Surgery

ROCKVILLE, Md., July 12 -- The FDA has approved a bifocal LASIK approach in which one eye will be treated for myopia and the other presbyopia.

The new device, called CustomVue Monovision LASIK, will reduce the need for reading glasses for adults 40 and older who have laser in-situ keratomileusis surgery to correct distance vision, said Daniel Shultz, M.D., director of the FDA's Center for Devices and Radiological Health.

The approval covers an eye mapping system using wavefront-guided treatments.

As part of the approval the FDA has requested a post marketing study following 500 patients for six months after surgery to characterize both quality-of-vision and quality-of-life issues associated with the procedure.

The surgery is a procedure in which the surgeon cuts a flap in the outer layer of the cornea in order to remove a small amount of tissue. The flap is then replaced. The CustomVue device would correct all nearsightedness in the dominant eye and only part of the nearsightedness in the other eye.

According to the FDA, patients considering the CustomVue Monovision LASIK surgery should first wear monovision contact lenses to determine whether they can tolerate having one eye under-corrected.

The surgery permanently changes the cornea, and side effects may include sensitivity to bright lights. These may be visual disturbances such as halos around lights and night-driving glare. Other potential side effects are double vision and visual fluctuation.

The device is made by AMO/VISX Inc., of Santa Clara, Calif.