FDA OKs New LASIK Device
CustomVue Monovision LASIK May Cut Some People's Need for Reading Glasses
July 12, 2007 -- The FDA has approved the CustomVue Monovision LASIK device,
the first LASIK device designed for treating one eye to see faraway objects and
the other eye for close-up 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," the FDA's Daniel Schultz, MD, says in an FDA news
"Unlike traditional LASIK, Monovision LASIK may reduce the need for
reading glasses in some people over 40," says Schultz, who directs the
FDA's Center for Devices and Radiological Health.
LASIK, or laser in-situ keratomileusis, is a procedure in which the surgeon
cuts a flap in the outer layers of the cornea, removes a small amount of the
tissue beneath it with the laser, and then replaces the flap.
CustomVue Monovision LASIK
CustomVue Monovision LASIK produces monovision correction in nearsighted
(myopic) adults with or without astigmatism who are at least 40 years old and
have normal, age-related problems focusing on nearby objects (presbyopia).
The CustomVue device is designed to correct all nearsightedness in the
patient’s dominant eye and only part of the nearsightedness in the nondominant
eye. This allows the patient 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.
Candidates for Monovision LASIK
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, according to the FDA.
Following monovision surgery, the two eyes may not work together as well as
they did before in some patients, especially in dim light or when performing
tasks requiring very sharp vision or fine depth perception, the FDA also
Patients may need to wear glasses or contact lenses for some activities such
as night driving or reading small type.
Possible Monovision LASIK Side Effects
CustomVue Monovision LASIK is a permanent operation to the cornea.
Side effects may include glare from bright lights, rings around lights
(halos), light sensitivity, night driving glare, ghost images, double vision,
and visual fluctuation, notes the FDA.
CustomVue Monovision LASIK is made by AMO/VISX of Santa Clara, Calif. The
FDA approved the device after reviewing a clinical study submitted by
At the FDA's request, AMO/VISX will conduct a post-approval study following
500 patients for six months after surgery to note quality-of-vision and
quality-of-life issues associated with permanent LASIK monovision
The objective of that study is to estimate the percentage of monovision
LASIK patients who experience visual disturbances that are severe enough to
limit activities or adversely affect a patient's quality of life.
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