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Home > Archive > Lasik Eyes Surgery > September 2005 > FDA reports high percentages of patients with worse vision
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FDA reports high percentages of patients with worse vision
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| FDA referemces 2005-09-24, 2:39 pm |
| The following results were obtained in the FDA LASIK Clinical Trials in
2002. These statistics are from the laser manufacturer, using the best
doctors in their trials.
<http://www.fda.gov/cdrh/pdf/P990027S002b.pdf>
Table 12, page 17;
36.6% night driving problems worse
37.7% vision in dim light made worse
42.9% haloes made worse
37.9% blurred vision made worse.
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| Ragnar 2005-09-24, 2:39 pm |
| Your message was useful in showing why the B&L Technolas is not a good
laser system and why just about nobody uses it. Find a study on the
market leader - VISX please.
Anyway, I would suggest that if someone finds out their surgeon is
using the Technolas, Nidek, or Ladarvision system... go someplace
else.
LVI has a slick trick. They have both the VISX and NIDEK systems,
however, they count on their patients not knowing the difference, and
at the last moment they decide to use the NIDEK. That is like
ordering filet mignon and the waiter substitutes salisbury steak.
Anyway, if you go to nearly the bottom of the pdf link below, you will
notice that off all the patients in the study, only 2.6% of them were
dissatisfied. If this is the most negative data you can find, then
everyone with myopia should RUN to their nearest LASIK surgeon.
Also, I have a feeling that whoever wrote that study was an idiot. If
you look at the chart from where the numbers below are pulled, you
will see that these same patients had virtually no complaints about
astigmatism, haze, floaters, or starbursts.
How can roughly 40% of these patients be complaining about halos and
blurred vistion when less than 1% of them are complaining about
starbursts and haze? That is a severe contratiction.
On Sun, 4 Sep 2005 12:25:02 -0400, "FDA referemces"
<FDAreferences@MSN.com> wrote:
>The following results were obtained in the FDA LASIK Clinical Trials in
>2002. These statistics are from the laser manufacturer, using the best
>doctors in their trials.
>
><http://www.fda.gov/cdrh/pdf/P990027S002b.pdf>
>
>Table 12, page 17;
>
>
>
>36.6% night driving problems worse
>
>37.7% vision in dim light made worse
>
>42.9% haloes made worse
>
>37.9% blurred vision made worse.
>
>
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| Glenn - USAEyes.org 2005-09-24, 2:39 pm |
| "High percentage" is relative. According to our Quality Standards
Advisory Committee, approximately 3% of refractive surgery patients
will have an unresolved complication at six months postop with 0.5%
being serious complications requiring extensive maintenance or
invasive procedures to resolve. Most studies show the loss of best
corrected visual acuity for current procedures to be within these
percentages.
For some, 3% may seem high. For others, that may seem acceptable.
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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