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FDA approves CustomVue monovision LASIK

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The U.S. Food and Drug Administration recently approved Advanced Medical Optics' CustomVue laser platform for performing monovision LASIK, the agency announced in a press release. This is the first laser platform to receive marketing clearance for monovision LASIK, the release said.

CustomVue monovision LASIK is indicated for myopic adults age 40 years or older with normal age-related presbyopia either with or without astigmatism. The procedure corrects the full amount of myopia in the patient's dominant eye and only part of the myopia in the nondominant eye.

The FDA based approval on review of clinical safety and efficacy data submitted by AMO, the release said.

However, at the FDA's request, AMO will conduct a post-approval study that will follow 500 patients for 6 months postop to assess quality of vision and quality of life outcomes related to permanent LASIK monovision correction, the release said.

"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," the release said.

AMO representatives were contacted but declined to offer immediate comment.