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LASIK clinical studies submitted to FDA


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LASIK clinical studies submitted to FDA, Ting - Toronto, WY, 4/22/2004
Correction to the Urls provide..., Ting - Toronto, WY, 4/22/2004, (#1)
Corrections to the Urls , agai..., Ting - Toronto, WY, 4/22/2004, (#2)

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"LASIK clinical studies submitted to FDA"
Posted by Ting - Toronto, WY on 15:07:30 4/22/2004
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This is a question for the doctors.
Background:
I am considering LASIK for me 42 years, OD: -5.00 -1.75 005 OS: -5.25 -2.25 175. My main concerns are: floaters impact on WaveFront-Guided laser, Pollen alergy (itchy eyes, VERY stuffy nose) impact on healing process. In an effort to assess the risk for "me" - astigmatic myopia with the above prescription, I have read the clincal studies for myopia submitted to FDA by B&L for Technolas 217z, WaveLight Laser Technologie AG for Allegretto Wave and VISX for VISX Star S4 obtained from the following address: http://www.fda.gov/cdrh/pdf/P990027S006c.pdf, http://www.fda.gov/cdrh/PDF2/P020050c.pdf and http://www.fda.gov/cdrh/pdf/p930016S016c.pdf. I am not a doctor.

Question: all three studies show that (all eyes, i.e. no break down of spherial myopia only, etc. ) 90+% patients see 20/20+ UCVA post-op yet only about 75% see same or better "UCVA post-op" vs. "BSCVA pre-op". What explains the gap? One logical assumption is that 15% patients saw 20/15+ BSCVA pre-op. They do not see 20/15+ UCVA post-op but they see 20/20 UCVA post-op. Does this assumption make sense from your medical experience?
Also, I would appreciate it if you could address my concerns about floaters, allergy and point me to any studies with specific break down of "astigmatic myopia" like the one on page 3-24 of the above VISX study where I can see clearly that for astigmatic myopia with Sphere in the range of -5D to -6D I have 70%, 85% seeing 20/20+ and 20/40+ UCVA respectively.

Thank you very much in advance.

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1. "Correction to the Urls provided"
Posted by Ting - Toronto, WY on 15:16:57 4/22/2004
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http://www.fda.gov/cdrh/pdf/p990027s006.html, http://www.fda.gov/cdrh/PDF2/p020050.html and http://www.fda.gov/cdrh/pdf/p930016s016.html

click on Professional Labeling after clicking on any of the Url.

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2. "Corrections to the Urls , again"
Posted by Ting - Toronto, WY on 15:23:15 4/22/2004
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Sorry, let me try again.
http://www.fda.gov/cdrh/pdf/p990027s006.html , http://www.fda.gov/cdrh/PDF2/p020050.html and http://www.fda.gov/cdrh/pdf/p930016s016.html

click on "Professional Labeling" after clicking on any of the Url.

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