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Author Custom wavefront LASIK has 10% dissatisfaction rate in clinical trials
FDA referemces

2005-09-24, 2:39 pm

Clinical trials use the best doctors and best screened patients to maximize
the chance of a good outcome. Ten percent dissatisfaction is not a good
outcome. See below.

Wavefront LASIK, which was developed to prevent some aberrations caused by
standard LASIK has a 9% patient dissatisfaction rate! (Source, FDA
transcripts
<http://www.fda.gov/ohrms/dockets/ac...ipts/3883t1.doc> ).


Glenn - USAEyes.org

2005-09-24, 2:39 pm

Here we have the resident anti-LASIK troll hiding behind yet another
alias and once again and trotting out "data" that has already been
discussed, clarified, and found to be not quite accurate.

Way back in May of 2003 when Ron Link (disgraced former head of
SurgicalEyes) threw this out as some sort of justification for his
anti-LASIK mania, I corresponded with Michael Grimmett, MD, who is the
individual who made this nearly forgotten 9% dissatisfaction rate
statement at an FDA meeting.

The initial FDA protocols limited the doctors' ability to respond to
the cause of these patients' dissatisfaction. As an example, to keep
the clinical trial's data "pure", patients who were undercorrected
were not able to have enhancements or additional treatment/management
that would have resolved their dissatisfaction until after the
clinical trial.

As part of the FDA trial, protocols were established that determined
how much correction (tissue removal) would occur for a given amount of
myopia. Early in the trial, Alcon found that a particular treatment
algorithm, which was used to treat a specific amount of myopia, was
under correcting patients. Alcon wanted to change the algorithm, but
the FDA required them to use the same algorithm throughout the trial
so that there would be no differences across the centers or physicians
in the trial. Those patients who were under corrected were those who
were dissatisfied. Those patients were later retreated and corrected.
The trial dissatisfaction rate, then, is an artifact (anomaly) of the
trial protocols. In actual clinical settings - the real world -
physicians treat patients appropriately.

I'm sure the poster knows the truth about all of this. In fact I have
no doubt, but truth will never stop a zealot.

For those keeping score, this qualifies for NetLoon identifiers:

6) Makes a statement that is widely known to be a misrepresentation of
a researcher's published conclusion. (+ 30 points).

7) Makes a statement that is widely agreed on to be false. (+10 points
per statement)*

18) Repetitively "forgets" (or ignores) factual information, provided
by others in earlier discussion thread(s), that disproves (or is
strong evidence against) their hypothesis. (+ 30 points).*

Glenn Hagele
Executive Director
USAEyes.org

"Consider and Choose With Confidence"

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.
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