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CustomVue Monovision LASIK - FDA Approves A New LASIK Device 

 

In July 2007 the FDA approved the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision. Approval of the CustomVue Monovision LASIK expands permanent vision correction options for many nearsighted adults who also have trouble focusing on any objects close-up.

Not like the traditional LASIK, Monovision LASIK might reduce the need for reading glasses in some people who are over 40.

LASIK  (an acronym for 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 a laser, and then replaces the flap.

CustomVue Monovision LASIK produces monovision correction in nearsighted adults, whether they have astigmatism or not, ages 40 years or older with normal age-related loss of ability to focus on near objects.

This 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 some period of time, we don't know how long that is, the brain adjusts to the difference in perception between the two eyes.


The FDA said people who are considering having CustomVue Monovision LASIK should first wear monovision contact lenses for at least one week so they can decide if they can tolerate having even one eye under-corrected.

Be aware that after 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 still 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.  It can't be reversed. Some of the side effects can include glare from bright lights, rings around lights (halos), light sensitivity, night driving glare, ghost images, double vision, visual fluctuation and perhaps others not known at this time.

CustomVue Monovision LASIK is manufactured by AMO/VISX Inc..  They are based in Santa Clara, California. This new approval is for the monovision correction, which uses the previously approved wavefront-guided treatments, which is an eye-mapping system that guides the laser, for myopia and astigmatism. FDA based its current approval on the review of a clinical study of safety and effectiveness outcomes submitted by the company.

At the request of the FDA, 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 this new study is to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit their or adversely affect a patient’s quality of life.

Be very careful if you are considering a new procedure like the CustomVue Monovision Lasik procedure. Often with new procedures there are problems that only time will produce. As with any new drug, wait five years and see what happens in terms of side effects.  It can't be reversed and we are talking about your precious eyesight. Wait and see if you are thinking about this at all.