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Lasik eye laser surgery risks to be studied in US   |   12.11.2009
The US Food and Drug Administration (FDA) have sent warning letters to 17 clinics in the US that perform Lasik eye laser surgery.

Inspections revealed that there were inadequate systems for reporting unexpected side-effects, leading the US government department to issue the warnings.

Last month, the FDA announced it had launched a study alongside the National Eye Institute to look at the potential impact on the quality of life that Lasik eye laser surgery could have.

The study has been split into three phases, with Phase 1 (which started in July 2009) being a questionnaire assessing outcomes reported by the surgery.

Phase 2 will evaluate the quality of life and satisfaction ratings, while phase 3 that will end in 2012 will be a national clinical trial that will look at the impact on quality of life of the procedure.

Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said: "This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects from the procedure."

Commenting on the news, Jennifer Golden from i-Go Lenses said: "i-Go over night contact lenses were launched as a new alternative to eye laser surgery.

"They offer the benefits of natural daytime vision without any of the potential risks of surgery."

Although the risks of eye laser surgery are minimal, ortho k contact lenses offer absolutely no risks and are a perfectly natural way to restore vision without the need for invasive procedures such as Lasik.

By Chris Alexander
ADNFCR-2387-ID-19457214-ADNFCR



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28 September 2009 

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