Lasik Eyes Surgery - LASIKtruth website contents

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LASIKtruth website contents

2005-09-24, 2:38 pm

Exposing the LASIK Industry

This site will detail the failure of the Ophthalmic Devices Panel of the FDA
to ascertain that LASIK was safe before approving it, and other revealing
information about the LASIK money-machine.

We begin with a little history:

Dr. Casebeer is considered the "Father of Refractive Surgery"

In 1999 Dr. Charles Casebeer and Dr. Guy Kezirian submitted a study to the
FDA Ophthalmic Devices Panel for approval of the VISX laser for LASIK (it
was previously approved only for PRK). Casebeer introduced himself as the
Chairman and founder of CRS Clinical Research, the applicant for the
Premarket Approval (PMA). CRS/Casebeer hired Dr. Kezirian as a consultant
for the study. While the manufacturer's name has been blacked out by the
FDA, the timeline suggests that this warning letter was in regards to the
VISX study. The letter states the FDA audit of CRS was in May, 1999, the
FDA panel meeting for the approval of the VISX laser for LASIK was in July,
1999, and the letter is dated August, 1999.

The inspection revealed several deviations from FDA guidelines which seem to
suggest that the study was a sham. CRS was informed that their statement
"The sponsors do not assume responsibility for monitoring individual
results" did not release them from their responsibility for data monitoring
and validation.

At the bottom of this page are excepts from an article that Dr. Casebeer
wrote to his peers about the profitability of refractive surgery, as well as
a link to his complete article.

July 22-23, 1999 FDA Ophthalmic Devices Panel Meeting

http://www.fda.gov/ohrms/dockets/ac...scpt/3528t1.pdf

This document is over 200 pages long, but careful reading exposes the
following:

Ron Link (as a representative for the American public) begins speaking to
the panel on page 21. He asks the panel to raise the standard of care by
defining what a complication is (including ghosting, starbursts, halos,
etc), and better pre-op evaluation and testing including pupil measurement,
contrast sensitivity measurement, predisposition to vitreous detachment, and
better informed consent relative to each person's unique set of eyes. He
also (page 24) calls for complication tracking. He tells the panel that
when Dr. Casebeer wrote the manual on RK(radial keratotomy), there was no
mention of pupil size, even though Drs. Applegate and Holliday had warned of
pupil size in previous scientific journals.

When Ron Link spoke, it was during the first 30 minute open public hearing.
Chairman McCulley allowed 3 surgeons to speak before he allowed Ron and
Mitch Ferro (also representing the public) to speak... basically allowing
Casebeer's cronies to "eat up the clock". By the time it was Mitch's turn,
McCulley told Mitch he only had 2 minutes.

When Mitch Ferro spoke, (page 27), he testified to being visually impaired
by LASIK due to having 8mm pupils. He spoke of starbursts, halos, and
ghosts. He asked the panel to consider expanding the study parameters to
include pre- and post-op contrast sensitivity testing, glare testing, and
diplopia. He further asked the panel to limit the laser's approval based
not only on refractive error, but also on pupil size (page 28). He also
called for regulating the advertising of LASIK to include warnings as to the
possible risks and complications.

Casebeer and Kerzirian, a CRS consultant, presented the data on the VISX
study of LASIK. The accountability was very poor. So poor in fact that
Casebeer split the study into two groups. Group 1 (723 eyes) had 90% follow
up at 3 months and 76% at 6 months. Group 2 (553 eyes) had a much worse
follow up (accountability) rate, 57.5 percent at 3 months.

Casebeer effectively excluded 43 percent of the data by splitting the groups
and reporting only the better group of follow-up for the PMA.

Dr. Ferris (Good Doc #1) on page 71 expresses concern about this "... and I
think that is the concern that the bigger that portion is that we are
missing if we are looking for balancing a small negative effect or at least
trying to allow the patients to know what the degree of negative effect is,
when there is a lot of missing data it is very difficult to assess that."
Page 104 "... the only comment I would have is that my concern is that I
don't know what the complication rate truly is lurking out there."

Dr. Bullimore speaks about the issue of accountability on page 82: "Overall
the accountability is less than 75% at 3 months and less than 63% at 6
months". Then he makes a startling observation about Casebeer's cronies who
used the 30 minute open hearing to try to convince the panel to approve the
PMA... The 3 doctors were investigators for this study. One of the doctors
was in the bad follow-up group that was deleted from the PMA group and
another one just barely made the cut. Dr. Bullimore "I was, also, intrigued
to note that of the three physicians who made presentations to the Panel,
one of them wasn't included in the PMA cohort and a second actually just
made the cut. So this is a constant source of concern for me..." He
continues "... we don't know anything about the 30-something percent who are
not seen at 6 months". Then Bullimore says something really outstanding
"... there is still need for a standardized questionnaire or instrument to
be used for the assessment of patient satisfaction following these
procedures".

Dr. Pulido speaks on page 89 about the accountability issue "I have strong
concerns regarding accepting the study as a whole because of the data set
and if the FDA accepts this kind of study where accountability is only 57
percent..... The doctors should be chided for bad science, and if they
enroll patients into a study, they should be ethically bound to follow up on
these patients" . Page 112: "I really would like your help because if I
can get over this accountability problem, this accountability hurdle, I
would be very happy in accepting and approving this FDA submission."

Dr. Macsai (Good Doc #2) on page 98 reading from the FDA Guidance Document:
"The loss to follow-up typically should not exceed 10 percent at one year,
and I have a great deal of difficulty with an accountability of 50 to 76
percent at 6 months".

Here is a link to the FDA Guidance Document that they supposedly followed
while conducting the study:

http://www.fda.gov/cdrh/ode/2093.html

This document clearly calls for pupil measurement... but CRS did not control
for pupil size (or for dry eyes).

Back to the panel meeting:

Page 107 - McCulley "Was pupil size looked at apropos of the public
comments"

Dr. Kezirian "Pupil size was not one of the considerations in this
protocol".

They gave patients a subjective questionnaire to complete afterwards. On
page 55, Kerzirian states "clearly one of the frontiers in LASIK is to
actually try to improve quality of vision... we aren't there yet with that".
What he didn't say was that 26% reported worse halos than before LASIK (see
page 121 when Dr. Mascai does her own math to derive at a complication rate
for halos).

Dr. Mascai (page 121) ... "I calculated that 26 percent of the patients were
complaining of halos on the worst side and 26 percent of visual
fluctuations?" Page 122 "... is it fair to say that 26 percent complained
of worsening of halos whether it be mild, moderate or severe?"

Dr. Wang makes a statement about the difference between pre and post op
halos on page 129 "I have a question about visual quality.... Specifically
regarding halo, we know that clinically the halo experience after LASIK
tends to be more visually significant and affecting the quality of vision
than halos that occur naturally in patients without ever having surgery....
the pre op halo comes from asphericity of corneal lens combined optics where
post-op comes from this artificial excavation of cornea just like volcano on
surface of the cornea, but off sharply at 6 millimeters. Have you attempted
to assess the degree of halo because from my clinical experience those halos
that occur after LASIK tend to be more significant".

Here's the part where it gets good...

Page 130

Dr. Bullimore, addressing Casebeer "Firstly, do you think pupil size is an
important factor in patient satisfaction with this procedure?"

Casebeer: "As a personal matter, I mean do I, personally, think that"?

Bullimore "Does the sponsor believe that pupil size is an important
determinant in -- okay"

Casebeer "I want to answer, but it doesn't seem appropriate"

McCully (bailing out Casebeer) No, I think you told us before you did not
assess pupil size"

Casebeer "Correct, so we have no opinion".

In 1996, Dr. Casebeer co-authored an authoritative text on laser vision
correction and the warnings about pupil size with regard to refractive
surgery were clear. The book is called "Lamellar Refractive Surgery."
casebeer.pdf

On page 80, Dr. Mannis expresses his concern about the halos after LASIK.
"... 20 percent of the patients were subjectively worse in terms of glare...
there was clearly 20 percent incidence of some visual dysfunction... perhaps
non-acuity parameters should be evaluated over the entire range of
refractive error in this procedure".

We always hear how LASIK is so effective??!! Not according to the data
submitted for this PMA. See page 49. Only 39% of the eyes over 7 diopter
of myopia achieved 20/20 vision! (on page 79 it says only 35% of the high
myopes achieved 20/20). And for eyes less than 7 diopters it was only 59%.

We also hear how LASIK is safe?!?! Read page 78. 7.1 percent of high
myopes had less than 20/40 BSCVA at 6 months after LASIK.

On page 150, Dr. Van Meter offers an out: "We can get around this with
appropriate informed consent".

A spokesman makes VISX position very clear about the well-being of patients
on page 173 "... the investigators are the ones who have a moral, ethical,
and medical-legal responsibility to the patients. We do not, okay?"

But wait, Casebeer tried to shirk his responsibility to the patients in the
material he presented to the FDA, which earned him an FDA reprimand.
Casebeer wrote "The sponsors do not assume responsibility for monitoring
individual results". The FDA fires back in the warning letter "Such a
statement cannot serve to release a sponsor from their responsibility. Data
validation is part of monitoring and, as noted above, Part 812 gives the
sponsor the responsibility for assuring that a clinical study is properly
monitored."

Warning letter from the FDA to Dr. Casebeer:
http://www.fda.gov/foi/warning_letters/m2875n.pdf

In voting for approval of the PMA, why did Bullimore cave in? Page 182 is
quite telling. Dr. Bullimore "... we are dealing with a procedure here
which has probably been performed on 100, 200, maybe 300 or more thousand
Americans and then performed by many people sitting around this table. So,
it is with that that I am sort of coloring my perspective on this PMA"

When the vote was in nine voted in favor, zero opposed, and two absentions.
Abstaining were Dr. Ferris and Dr. Macsai.

After the vote, page 192, Dr. Pullido stated "I voted yes only after I was
able to get some amendment showing that accountability was poor because that
was a real problem with the study, and again I don't want to see this kind
of study brought forward in the future".

Dr. Macsai " I cannot assess the safety and efficacy has been established
due to the lack of accountability.

Dr. Van Meter "I am, also, concerned about informed consent as patients view
this with the barrage of advertising that even though it is not under the
purview of this agency or this committee, is outside the range of this
discussion, but it concerns me, nonetheless. I hope we don't have a whole
lot more patients with accounts like we heard this morning (Ron and Mitch)
come forward with LASIK."

Dr. Ferris "... the data that were included in this PMA are not
scientifically adequate for approval".

Did Dr. Casebeer have any other motives for getting this approval? Check
out our Conflicts of Interest page!

Glenn - USAEyes.org

2005-09-24, 2:38 pm

1999? Six years ago? In refractive surgery terms, that is like dying
and being reincarnated three times over. Heck, Dr. Casebeer has been
retired for years.

All of the initial FDA trials have been superceded with additional
trials and laser improvements. All of the initial outcomes data has
been superceded with many, many additional studies. All of the
following data supported and refined the initial conclusions. If there
was any flaw in the initial studies, subsequent studies found the same
conclusions.

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.

2005-09-24, 2:38 pm

In article <1125185792.13f96df9b6809d7308cbf45c47bab5e2@teranews>,
"LASIKtruth website contents" <LASIKtruth website contents@nospam.com>
wrote:

>
> July 22-23, 1999 FDA Ophthalmic Devices Panel Meeting

this is a fascinating read, but could you please explain the relevance
in 2005 for someone considering the procedure? the technology has come
a long way in 6 years, and will probably be well ahead of the present
day in another six years. The good thing is that doctors are learning
from their mistakes and there is a more strict protocol for identifying
potential LASIK consumers--pupil size being one of the factors
considered as well as the level of correction needed.

--
~RT

LASIKtruth website contents

2005-09-24, 2:38 pm

Casebeer is still doing expert witness work. In a recent court case,
Casebeer testified
that all LASIK eyes are bulging. Nice, huh? Reassuring news for all of the
patients
out there who have had this surgery.

Yes, subsequent studies have found consistently increased higher order
aberrations, even with wavefront LASIK,
consistent, universal loss of contrast sensitivity, flaps that never heal
that can be lifted (or dislodged accidentally)
years later, and junk under the flap. Some things never change. Recently it
has been shown that LASIK
nerve damage is greater than 40% at the 3 year point. Too bad patients
aren't made aware
of these facts.

Like tobacco and Vioxx, the LASIK industry moved forward with a motive of
profit the higher priority
over patient welfare. Sickening.

"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:dku1h1pu9ro2o143p11fm3pn2q3p6m1vit@4ax.com...
> 1999? Six years ago? In refractive surgery terms, that is like dying
> and being reincarnated three times over. Heck, Dr. Casebeer has been
> retired for years.
>
> All of the initial FDA trials have been superceded with additional
> trials and laser improvements. All of the initial outcomes data has
> been superceded with many, many additional studies. All of the
> following data supported and refined the initial conclusions. If there
> was any flaw in the initial studies, subsequent studies found the same
> conclusions.
>
> 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.

LASIKtruth website contents

2005-09-24, 2:38 pm

This is a history lesson, folks. Of what went wrong in the begginnings of
LASIK, and who the players
were who were involved in the process.

LASIK hasn't changed much. They still cut a flap which severs corneal
nerves. The corneal integrity
is not restored - same as in 1999. Patients still lose contrast sensitivity.
The new wavefront LASIK
still induces aberrations in the cornea... 20% less than standard LASIK, but
it induces them. The
new custom wavefront treatments eat more corneal tissue, leaving the cornea
thinner, and the patient
less able to receive retreatment if needed, and more vulnerable to ectasia.

My idiot surgeon said pupil size didn't matter. I have 8 mm pupils, a 6mm
optical zone
and ruined vision. In 2004 on the most modern laser - I don't think doctors
are learning much.
This happened at a famous research hospital. The LASIK doctors there
supposedly train
other surgeons and 'fix' botched LASIKs from other centers. From what I have
been hearing,
people don't really get 'fixed' very often. These guys love to take the
money of these desperate
victims and then tell them 'time is on their side'. That something WILL come
along to fix them.

That's one of the great myths of LASIK. Some patients have been waiting
years for these fixes.
LASIK surgeons have no idea how to fix their casualties. They can't do it.

"RT" <RTMD24@NOSPAMyahoo.com> wrote in message
news:RTMD24-19188A.19492527082005@newsclstr01.news.prodigy.com...
> In article <1125185792.13f96df9b6809d7308cbf45c47bab5e2@teranews>,
> "LASIKtruth website contents" <LASIKtruth website contents@nospam.com>
> wrote:
>
>
> this is a fascinating read, but could you please explain the relevance
> in 2005 for someone considering the procedure? the technology has come
> a long way in 6 years, and will probably be well ahead of the present
> day in another six years. The good thing is that doctors are learning
> from their mistakes and there is a more strict protocol for identifying
> potential LASIK consumers--pupil size being one of the factors
> considered as well as the level of correction needed.
>
> --
> ~RT
>

Glenn - USAEyes.org

2005-09-24, 2:38 pm

ROFLOL

What a joke. Casebeer said "all LASIK eyes are bulging"!? That is
hilarious. How about a transcript of this "recent court case". What a
crock.

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.

Glenn - USAEyes.org

2005-09-24, 2:38 pm

Just as an exercise in futility, lets go through each of these points.

>This is a history lesson, folks. Of what went wrong in the begginnings of
>LASIK, and who the players
>were who were involved in the process.

Nothing "went wrong" in the process to bring one of the most
successful elective surgical procedures to the United States that is
inconsistent with any other new technology and/or technique.

The best surgeons are often hired by many different companies to
advise and design. That does not automatically create a conflict of
interest.

Considering that virtually every single issue of fact presented to the
FDA in the process of achieving initial approval for the excimer laser
in the first place has been affirmed - and sometimes refined - in
subsequent studies is testament to the fact that nothing "went wrong".

>LASIK hasn't changed much.

Really? The femtosecond laser microkeratome did not exist in 1997.
Neither did the zero compression head for the Hansatome mechanical
microkeratome. Wavefront analysis for ophthalmology did not exist.
Wavefront-guided ablation did not exist. Small beam flying spot lasers
did not exist. Eye tracking did not exist. The list of improvements
and refinements goes on and on and on.

>They still cut a flap which severs corneal
>nerves.

Yes, however the sensitivity of the corneal nerves normally returns
within the usual six-month healing period. Nerve density - a
measurement of restoration of the cornea - returns to preoperative
levels at three years for PRK and five years for LASIK.

>The corneal integrity
>is not restored - same as in 1999.

And same as in the 1950s when Barraquer and others started lamellar
corneal surgery, but since that time it has become very well
understood that so long as 250 microns of tissue in a health cornea
remains untouched, the cornea will remain stable. More is always
better, of course.

>Patients still lose contrast sensitivity.

As a general rule, contrast sensitivity is diminished with excimer
laser based refractive surgery, but not always. In some patients
contrast sensitivity will actually increase. The reduction of contrast
sensitivity is significantly less (again, overall) with
wavefront-guided ablation than conventional ablations. Yet another
thing that has changed since 1997.

>The new wavefront LASIK
>still induces aberrations in the cornea... 20% less than standard LASIK, but
>it induces them.

Fortunately, even with elevation of aberrations as measured with
wavefront devices, the vast majority of patients do not note
diminished vision quality. This is one of the areas where a complete
examination by a competent surgeon is so important. If a patient
naturally has elevated higher order aberrations, it may be best to not
have surgery at all. This kind of evaluation did not exist in 1997,
but does today.

>The
>new custom wavefront treatments eat more corneal tissue, leaving the cornea
>thinner, and the patient
>less able to receive retreatment if needed, and more vulnerable to ectasia.

Only if treatment would exceed the 250 micron threshold mentioned
above is any of this an issue. This is an issue for some patients, but
not for all. Most patients with thinner corneas can elect to have a
surface ablation technique like PRK, LASEK, or Epi-LASIK without
problem.

The rate of ectasia after LASIK is somewhere between 1 in 10,000 and 1
in 20,000. About the same as the rate of keratoconus in the general
population.

>My idiot surgeon said pupil size didn't matter. I have 8 mm pupils, a 6mm
>optical zone
>and ruined vision.

For all the details on the pupil size issue, visit
http://www.usaeyes.org/faq/subjects...pupil_size.htm, but it
appears we are seeing the real motivation behind your posts. You think
your surgeon screwed up. How you convert that into "all LASIK is bad
and nothing has changed since 1997" is beyond reasonable belief.

>In 2004 on the most modern laser -

No amount of technology can compensate for an inferior surgeon (if
that was actually the case here).

>I don't think doctors
>are learning much.

So then you are saying that you think years of peer-reviewed studies,
tens of thousands of hours of continuing education meetings, multiple
additional FDA clinical trials, the advancement of entire subsets of
lasers, etc. etc. all are being ignored. Not at all true.

>This happened at a famous research hospital. The LASIK doctors there
>supposedly train
>other surgeons and 'fix' botched LASIKs from other centers. From what I have
>been hearing,
>people don't really get 'fixed' very often.

Then you have been hearing wrong.

I don't know about the doctors to whom you refer, but I know
absolutely for a fact that many patients who had problems have had
those problems either resolved or improved with additional treatment.

>These guys love to take the
>money of these desperate
>victims and then tell them 'time is on their side'. That something WILL come
>along to fix them.

Ah yes, and now we get to the "refractive surgeons are all money
grubbing buggers" part. Just plain foolishness.

>That's one of the great myths of LASIK. Some patients have been waiting
>years for these fixes.

Some patients wait because their does not exist technology or
technique that can reliably resolve their problem. Some patients use
non-surgical techniques to resolve issues, such as the use of rigid
contact lenses (RGP) or Alphagan P to reduce pupil size and improve
night vision. Some simply will not have surgery no matter what the
probability that it will resolve their problem.

About 3% of refractive surgery patients have some sort of unresolved
complication at six months postop, with 0.5% being serious
complications requiring extensive management or invasive care to
resolve.

>LASIK surgeons have no idea how to fix their casualties. They can't do it.

Absolutely not true in all cases.

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.

serebel

2005-09-24, 2:38 pm

Not much truth from "Lasiktruth" at all.

SErebel