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Home > Archive > Lasik Eyes Surgery > December 2005 > Charles Casebeer's company, CRS, ran shoddy VISX/Summit LASIK clinical trials
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Charles Casebeer's company, CRS, ran shoddy VISX/Summit LASIK clinical trials
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| Charles Casebeer's company, CRS ran the shoddy VISX/Summit (later
becomes Alcon) LASIK clinical trials. This is where the trail of deceit
and coverup starts.
Notice their benchmark for success is 20/40 which is the barely legal
limit for driving and does NOT represent good vision. IF you're a high
myope your chances of reaching even this low benchmark are just a
little better than 50%. Clinical trials are performed on the best
screened patients by the top gun surgeons. Why weren't these stats
reported to patients in the labeling? Notice how poor the outcomes are
for high myopes!
http://www.ncbi.nlm.nih.gov/entrez/...8651&query_hl=5
Outcomes of spherocylinder treatments in the comprehensive refractive
surgery LASIK study.
Casebeer JC, Kezirian GM.
Department of Ophthalmology, university of Utah, Salt Lake City, UT.
The CRS LASIK Study is a surgeon-sponsored collaborative project to
evaluate LASIK outcomes with the Summit and VISX lasers. The current
report includes 3-month outcomes in the first group of patients who
underwent spherocylindrical corrections of 1 to 10 diopters of myopia
and 1 to 4 diopters of astigmatism with the Summit Apex Plus and VISX
Star lasers.
Cohort selection criteria were applied to select 911 eyes that
underwent surgery between April 1, 1996 and October 1, 1997 in the
range of study. Eyes with preoperative best spectacle-corrected visual
acuity of worse than 20/40 (0.5) were excluded.
Outcomes were stratified according to myopic treatment range. One day
uncorrected visual acuity was 20/40 or better in 83% of eyes with both
lasers.
At 3 months, 20/40 uncorrected acuity was found in 93% of Summit and
90% of VISX eyes in the -1.00 to -4.00 D group, in 88% of Summit and
84% of VISX eyes in the -4.01 to -7.00 D group, and in 67% of Summit
and 70% of VISX eyes in the -7.01 to -10 D group.
Three-month manifest refractive outcomes in the -1.00 to -4. 00 D group
were within +/- 1 D of target in 91% of the Summit eyes, and 89% of the
VISX Eyes. In the -4.01 to -7.00 D range, 72% of the Summit eyes and
74% of the VISX eyes fell within +/- 1 D, and in the -7.01 to -10 D
range, the rates were 53% for Summit and 56% for VISX.
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| Glenn - USAEyes.org 2005-12-18, 1:04 am |
| Yes, the outcomes for high myopes (nearsighted, shortsighted) patients
on the very first generation of lasers that were going through the FDA
approval process about a dozen years ago were not nearly as good as
the fourth-generation iris recognition wavefront-guided flying spot
lasers available today. Even still, the results then were remarkable
and led to approval of the device and over about 5 million procedures
to date (mostly on subsequent lasers).
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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| CatmanX 2005-12-18, 1:04 am |
| What this letter refers to is the absence of paperwork and red tape. It
has nothing to do with the quality of research or suggests in any way
that there was any flaw in the methodology.
This work was done 9 years ago when Lasik was still very new and in the
USA, there was little work done on high myopes.
The main thrust is that he was replicating other studies that used the
same criteria, so when comparing, it would be easier to draw accurate
comparisions.
dr grant
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| This was early lasers from 1997 as others have pointed out. Lasik
discount centers probably still use those old lasers. Your chances of
20/40 is almost 100% with todays wavefront but quality of vision is
another story, however its not always lousy. Even todays lasers promise
a reduced dependancy on glasses. Look everywhere, you will see it says
'reduced' if your expecting perfect vision from lasik your setting
yourself for disapointment. Everyone whos middle age will need reading
glasses after lasik unless they compromise with monovision. Many people
regress or get overcorrected or induced astigmastim and need glasses.
20/40 vision is good enough to not need glasses for some time. Of
course someone who was seeing 20/20(or better!) with glasses may feel
disapointed unless he has presbyopia. The bottom line is expect to be
closer to plano and need thinner glasses and not be functionally blind
without glasses.
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| I had LASIK surgery 5 years ago. My eyesight was particularly bad and I
was warned I would probably still need glasses afterward. The operation
was painless and after a week I had superhuman eyesight - I could
literally count the individual leaves on a tree 10 miles away. But my
near vision was crap. After a few months it balanced out and I had
perfect 20/20 in both eyes. However, 5 years later and I am still
putting drops in my eyes daily, I can not see nearly as well in near
dark light, I'm overly sensitive to light (like even the LED on the
bottom of my mouse is painful to look at at arms length) and I wear
sunglasses outside most of the time. I'm also susceptible to barometric
pressure where my eyes will go blurry for a day when the weather
changes. Still, I don't need glasses anymore, so I guess it was worth
it.
LOL talk about denial!
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| Information the FDA can use 2005-12-20, 1:05 am |
| Please explain the remarkable results then and how the results now are
better.
you wrote,
>the results then were remarkable
Glenn - USAEyes.org wrote:
> Yes, the outcomes for high myopes (nearsighted, shortsighted) patients
> on the very first generation of lasers that were going through the FDA
> approval process about a dozen years ago were not nearly as good as
> the fourth-generation iris recognition wavefront-guided flying spot
> lasers available today. Even still, the results then were remarkable
> and led to approval of the device and over about 5 million procedures
> to date (mostly on subsequent lasers).
>
> 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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| Information the FDA can use 2005-12-20, 1:05 am |
| Please explain the remarkable results then and how the results now are
better.
you wrote,
>the results then were remarkable
Glenn - USAEyes.org wrote:
> Yes, the outcomes for high myopes (nearsighted, shortsighted) patients
> on the very first generation of lasers that were going through the FDA
> approval process about a dozen years ago were not nearly as good as
> the fourth-generation iris recognition wavefront-guided flying spot
> lasers available today. Even still, the results then were remarkable
> and led to approval of the device and over about 5 million procedures
> to date (mostly on subsequent lasers).
>
> 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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| Glenn - USAEyes.org 2005-12-20, 1:05 am |
| I doubt I really need to explain the final FDA decision any more than
I need to explain the many advances since that decision.
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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