The U.S. Food and Drug
Administration 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
"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. "Unlike traditional LASIK, Monovision LASIK may
reduce the need for reading glasses in some people over 40."
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 produces monovision correction in nearsighted (myopic) adults,
with or without astigmatism, ages 40 years or older with normal age-related loss
of ability to focus on near 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 non-dominant
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.
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, 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.
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 glare from bright lights, rings around lights (halos), light
sensitivity, night driving glare, ghost images, double vision and visual
CustomVue Monovision LASIK is manufactured by AMO/VISX Inc., based in Santa
Clara, Calif. The new approval is for the monovision correction, which uses the
previously approved wavefront-guided treatments—an eye-mapping system that
guides the laser—for myopia and astigmatism. FDA based its approval on the
review of a clinical study of safety and effectiveness outcomes submitted by the
At FDA's request, AMO/VISX will conduct a post-approval study following 500
patients for six months after surgery to characterize quality of vision and
quality of life issues associated with permanent LASIK monovision correction.
The objective of the study is to estimate the proportion of monovision LASIK
patients who experience visual disturbances that are severe enough to limit
activities or adversely affect a patient's quality of life.
Facts You Need to Know About CustomVue Laser Assisted In-Situ
Keratomileusis (LASIK) Laser Treatment
Please read the patient information booklet completely. Discuss any questions
with your doctor before you decide if CustomVue LASIK is right for you. Only an
eye care professional trained in laser vision correction can determine whether
you are a suitable candidate.
Patient Information Booklet for High Myopia
Patient Information Booklet for Myopia
Patient Information Booklet for Hyperopia (Farsightedness)
Patient Information Booklet for Mixed Astigmatism
Patient Information Sheet - VISX Wavefront-Guided LASIK for
Correction of Myopic, Hyperopic, and Mixed Astigmatism