FDA Approves CustomVue Monovision LASIK

The U.S. Food and Drug Administration approved the marketing of the first LASIK device designed to treat an eye to see objects away and the other eye for close-up vision.

“The adoption of the CustomVue LASIK Monovision extends permanent vision correction options for nearsighted adults who also have difficulty focusing on close objects,” said Daniel Schultz, MD, director of the FDA Center for Devices and Radiological Health. “Unlike traditional LASIK, Monovision LASIK can reduce the need for reading glasses in some people older than 40 years.”

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 tissue underneath it with the laser, and then replacing the flap. CustomVue LASIK Monovision producing monovision correction nearsighted (myopic) adults, with or without astigmatism, ages 40 years or more normal age-related loss of ability to focus on objects close (presbyopia).

CustomVue The device is designed to correct nearsightedness in all patients eye dominant and only a portion of myopia in the non-dominant eye. This allows the patient to fully utilize the eye to correct vision at a distance and under the correction of eyes to see up close. After a period of time, the brain adjusts to the difference of perception between the two eyes.

People monovision consider CustomVue LASIK first use monovision contact lenses for at least a week to determine whether it can tolerate having one eye under corrected. Monovision After surgery, both eyes can not work together, as well as they did before in some patients, especially in dim light or when performing tasks that require vision very heavy fine or perception of depth. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small print.

CustomVue LASIK Monovision is an ongoing operation to the cornea. Side effects may include reflections from the bright lights, rings around lights (halos), sensitivity to light, night driving glare, ghosting, double vision and visual fluctuation.

CustomVue LASIK Monovision is manufactured by AMO / Visx Inc., headquartered in Santa Clara, Calif. The new approval is for the correction monovision, which uses the previously approved wavefront-guided treatments - an eye-mapping system that guides the laser — For myopia and astigmatism. The FDA based its approval on the examination of a clinical study of the safety and efficacy results presented by the company.

At the request of the FDA, AMO / Visx take place after approval of study after 500 patients for six months after surgery to characterize the quality of vision and quality of life issues related to LASIK permanent monovision correction. The objective of this study is to estimate the proportion of patients LASIK monovision visual experience that disturbances that are serious enough to limit activities or adversely affect a patient of the quality of life.

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