FDA Approves LASIK to Correct Both Myopia and Presbyopia

CustomVue Monovision LASIK will allow correction of myopia in dominant eye and undercorrection in non-dominant eye

THURSDAY, July 12 (HealthDay News) -- The U.S. Food and Drug Administration approved a LASIK device on Thursday that will allow the correction of myopia in one of a patient's eyes and undercorrection of myopia in the other. After treatment with the CustomVue Monovision LASIK, the patient can use one eye for distance vision and the other for near objects, which may reduce the need for reading glasses in patients over 40.

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

Before undergoing the procedure, patients must first undergo a trial period of at least one week, in which contact lenses are used to simulate monovision. After the procedure, some patients may still need to wear glasses or contact lenses for night driving or reading small type, according to the FDA.

Side effects may include glare, halos around lights, light sensitivity and other visual fluctuations or images. Some patients may have difficulty with fine depth perception or other activities that require binocular vision.

"The approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, in a statement. "Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people over 40."

More Information - FDA

Physician's Briefing