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 release.

“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 notes.

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 AMO/VISX.

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 correction.

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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