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Consumer Update |
FDA has approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision. The device is called CustomVue Monovision LASIK.
LASIK, or Laser-Assisted In Situ Keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the clear covering of the front of the eye (cornea), removes a small amount of the tissue beneath it with the laser, and then replaces the flap.
Monovision is a corrective technique used to treat people with presbyopia, which is normal age-related loss of the ability to focus on near objects. The intent is for the person to use one eye for distance viewing and one eye for near viewing.
"Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people over 40," says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health.
CustomVue Monovision LASIK produces monovision correction in nearsighted (myopic) adults, with or without an abnormal curve of the cornea (astigmatism), ages 40 years or older with presbyopia.
The CustomVue device is designed to correct all nearsightedness in a person's dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the person to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes.
People considering CustomVue Monovision LASIK should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye under-corrected. Following monovision surgery, both eyes may not work together as well as they did before in some people, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small type.
CustomVue Monovision LASIK is a permanent operation to the cornea. Side effects may include:
FDA based its approval on the review of a clinical study of safety and effectiveness outcomes submitted by the manufacturer, AMO/VISX Inc., Santa Clara, Calif.
At FDA's request, AMO/VISX will conduct a post-approval study. The study will follow 500 people for six months after surgery to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect their quality of life.
To learn more about LASIK eye surgery, visit http://www.fda.gov/cdrh/lasik/
Date Posted: July 13, 2007
