FDA Approves First LASIK Device for Monovision

LASIK is a surgical procedure approved by the U.S. Food and Drug Administration (FDA) intended to reduce a person's dependency on glasses or contact lenses. LASIK stands for Laser-Assisted In Situ Keratomileusis and has become a popular, but sometimes risky, eye surgery.

Now, there is a new LASIK device approved for treating monovision, and according to an FDA press release, "The approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted (myopic) adults who also have trouble focusing on objects close-up." Dr. Daniel Schultz, Director of the FDA's Center for Devices and Radiology Health, says, "Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in people over 40."

The LASIK procedure is one in which the surgeon cuts a flap in the outer layers of the cornea, removes some tissue beneath it using a laser, and then replaces the flap. LASIK monovision is a corrective technique used to treat an age-related loss of the ability to focus on close up objects. This is known as presbyopia. The CustomVue Monovision LASIK produces monovision correction in nearsighted adults, with or without an abnormal curve of the cornea known as astigmatism.

The CustomVue Monovision LASIK device is intended to correct all nearsightedness in the patient's dominant eye and only part of the nearsightedness in the non-dominant eye. The patient can then use the under-corrected eye for seeing close up things and the fully corrected eye for seeing things at a distance. The brain will eventually adjust to the perception difference of the two eyes.

CustomVue Monovision LASIK is manufactured by AMO/VISX, Inc. in Santa Clara, California. The new monovision correction uses previously approved wavefront-guided treatments as an eye-mapping system that guides the laser. There are possible side effects from this permanent operation to the cornea:

* Glare from bright lights
* Rings or halos around lights
* Light sensitivity
* Night driving glare
* Ghost images
* Double vision
* Visual fluctuation

The FDA recommends that people considering the CustomVue Monovision LASIK procedure should first wear monovision contact lenses for at least a week to see if the two eyes will work together properly when under-corrected. Even after the surgery, some patients may need to wear corrective lenses for night driving or reading very small print.

AMO/VISX will do a follow-up study for the FDA on its CustomVue Monovision LASIK device using 500 patients for six months. The company will report to the FDA, information about the patients' quality of vision and quality of life associated with the monovision LASIK correction.

Sources:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01665.html

http://www.allaboutvision.com/visionsurgery/outcomes_2.htm

http://www.fda.gov/cdrh/LASIK/when.htm