Exposing the LASIK Scam

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 Post subject: FDA: benefits of wavefront treatments small or nonexistent
PostPosted: Sun May 13, 2007 4:22 pm 
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FDA WAVEFRONT BENEFITS NONEXISTENT?

FDA Evaluation of Wavefront Guided LASIK
http://www.pcli.com/lasik/FDA_Evaluation.pdf

2 excerpts:

"Actual benefits are even smaller or nonexistent because variability from uncontrollable sources (eg, healing, aging, accommodation, pupil size, or ocular biomechanical effects) are typically larger than the errors treated."

"Manufacturers of devices for higher order aberration treatments have been motivated by market pressures to conduct premarket clinical trials before acquiring an understanding of the basic scientific mechanisms and developing appropriate clinical assessment tools."

Bruce Drum, PhD
FDA
Div. of Ophthalmic and ENT Devices
Office of Device Evaluation

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