Lasik Eyes Surgery - CRSQA responds to UK news reports

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CRSQA responds to UK news reports

rebeccaNO_SPAM@lasermyeye.org

2004-12-16, 9:25 am

I see that even though the NICE report hasn't been officially
published, you felt the need to intervene, Glenn.

British News Reports Of LASIK Problems Overstated, Says US Patient
Advocacy

UK government group states LASIK failure at more than three times
established rates.

For Immediate Release

SACRAMENTO, Calif./EWORLDWIRE/Dec. 7, 2004 --- A U.S. patient advocacy
organization says a British government draft report of the popular
laser eye surgery LASIK may significantly misrepresent complication
rates. British press has quoted a 10% rate of LASIK failure in the
U.K.'s National Institute for Clinical Excellence (NICE) report due to
be published later this month.

"Our organization has evaluated many medical studies and reviewed
thousands of LASIK patient outcomes," stated Glenn Hagele, executive
director of the nonprofit Council for Refractive Surgery Quality
Assurance (www.USAEyes.org). "About three percent of patients have some
sort of unresolved complication at the end of the normal healing
period, with less than one-half of one percent having a serious
complication that requires extensive maintenance or invasive
intervention."

LASIK, which is short for Laser Assisted In-situ Keratomileusis, uses a
laser to reshape the cornea of the eye to reduce or eliminate the need
for corrective lenses. Approximately 8 million LASIK or similar laser
eye surgery procedures have been performed since introduction in the
late 1980s. LASIK is the most often performed elective surgery in the
world. The U.K.'s National Health System (NHS) has declined to provide
British citizens LASIK, based partially upon perceptions of rates of
success.

"We are a patient advocacy group," said Hagele. "If complication rates
were higher, we would be the first to point it out." It is estimated
that there will be 1.2 million laser eye surgeries in the U.S. in 2004,
and about 100,000 in the U.K.

A potential source of conflicting information is the definition of
failure. "Refractive surgery is often more of a six-month process than
a 20-minute miracle", said Hagele, whose organization evaluates and
certifies LASIK surgeons in the U.S. and provides patient information
though its website. "There are occasions when patients are slightly
over or undercorrected and this may require enhancement surgery to
'fine tune' the result. Some patients may have a significant
improvement in vision, but not perfection and will require glasses on
occasion. Patients may experience temporary dry eye or fluctuation in
vision. In all but a relatively small, but important, minority of
cases, these issues are resolved with healing or treatment.

"If to be considered a 'success' LASIK must provide instantly perfect
vision with no healing time, then somebody has unreasonable
expectations. This is surgery, after all, and surgery requires time for
healing."

Although the NHS has declined to provide LASIK under its nationalized
healthcare program, the procedure is available though private clinics
throughout the U.K. "It would be surprising for a federal or private
health insurer to provide expensive elective surgery like LASIK. LASIK
treats a problem that can normally be corrected with spectacles or
contacts, which are significantly less expensive and certainly less
invasive than laser eye surgery."

About The Council For Refractive Surgery Quality Assurance
The Council for Refractive Surgery Quality Assurance is a nonprofit
patient advocacy organization formed in 1998 to provide objective
information about LASIK and similar eye surgery procedures in a
patient-friendly format through its www.USAEyes.org website. CRSQA also
certifies surgeons who complete its patient outcome evaluation and
oversight program.

HTML: http://newsroom.eworldwire.com/wr/120704/10922.htm
PDF: http://newsroom.eworldwire.com/pdf/120704/10922.pdf
ONLINE NEWSROOM: http://newsroom.eworldwire.com/305353.htm
LOGO: http://newsroom.eworldwire.com/305353.htm

CONTACT:
Glenn Hagele
Council for Refractive Surgery Quality Assurance
8543 Everglade Dr
Sacramento, CA 95826-3616
PHONE. 916/381-0769
FAX. 206/237-6545
EMAIL: glenn.hagele@usaeyes.org
http://www.USAEyes.org

WEBSITES: http://www.usaeyes.org, http://www.complicatedeyes.org

KEYWORDS: lasik, prk, lasek, epi-lasik, laser, eye, surgery, glasses,
contacts, complication, united kingdom

SOURCE: Council for Refractive Surgery Quality Assurance -
www.USAEyes.org

Glenn - USAEyes.org

2004-12-16, 9:25 am

>I see that even though the NICE report hasn't been officially
>published, you felt the need to intervene, Glenn.

I'm simply responding to the information already being reported in the
British press, and yes, I do feel the need to intervene when gross
misrepresentations are being propagated as fact.

It will be interesting to compare the statements made in the press
with the actual report.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

rebeccaNO_SPAM@lasermyeye.org

2004-12-16, 9:25 am

Glenn, the 10% failure rate you are responding to here has nothing to
do with the NICE report. It was reported by the Times originally in
June 2003. Since then it has simply become a journalistic habit in the
UK to use that warmed-over (and frankly confusing) statistic as filler
in new reporting about laser eye surgery.

Glenn - USAEyes.org

2004-12-16, 9:25 am

And so our press release sets the confusion straight.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

rebeccaNO_SPAM@lasermyeye.org

2004-12-16, 9:25 am

Oh.

You say that the press said that NICE said... but the press didn't say
that NICE said it, the press just said what the press has been saying
for a year and a half based on something somebody once said....
It's all clear as a bell now.

:-)

Glenn - USAEyes.org

2004-12-16, 9:25 am

Regardless of the contortions that the press and certain other parties
have been going through to suggest that LASIK has a 10%
complication/failure rate, (or it has only a 1% complication/failure
rate), our press release clearly states what our Quality Standards
Advisory Committee has been able to establish from the evaluation of
multiple studies and thousands of actual patient outcomes: About 3%
of patients have some sort of unresolved complication at six months
postop with about 0.5% having a serious complications that requires
significant maintenance or invasive intervention.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

gospa68@aol.com

2004-12-16, 9:25 am

Rebecca,
You are spot on!

It is most interesting (almost amusing) that a "patient advocacy" group
felt compelled to set the record straight. This same group,earlier this
year, felt compelled to testify (against) at the FDA panel meeting that
was reviewing phakic IOLs. It is most disingenuious to claim "patient
advocacy" when the behavoir of the CRSQA really stands for Lasik
Advocacy.

Glenn, we will love you all the same even if you admit to being a Lasik
advocate. However, you will not garner much love by trying to convince
us of something you are not. Unless, of course, you are a shizophrenic.

There is nothing wrong with advocating what you believe but calling
yourself and your organization a "patient advocacy" group is a
disservice to you, the CRSQA, and to those seeking unbiased
information.

WK

Glenn - USAEyes.org

2004-12-16, 9:25 am

>It is most interesting (almost amusing) that a "patient advocacy" group
>felt compelled to set the record straight.

It seems more interesting that anyone would think a patient advocacy
group would NOT feel compelled to set the record straight. Anyone who
claims to be a patient advocate who promotes misinformation or who
does not advocate for the dissemination of accurate information is not
an advocate for patients at all.

At least you acknowledge that we did set the record straight.

>This same group,earlier this
>year, felt compelled to testify (against) at the FDA panel meeting that
>was reviewing phakic IOLs.

WizKid, that is an outright lie that you must stop perpetrating it
immediately. The transcript of my presentation is public record and
affirms that at no time did I state or recommend that the FDA should
not approve the Veriseye/Artisan P-IOL. Never.

I raised valid concerns that I wanted the FDA to evaluate and consider
before they decided if this P-IOL should or should not be approved.
At the same meeting, a SurgicalEyes representative also raised
concerns about phakic intraocular lenses, as did others. In fact, the
final vote was a tie with an equal number of voting members against
approval as were for approval.

For all your complaining about the fact that we presented concerns to
the FDA, you have never once factually challenged any of the concerns
we raised.

> It is most disingenuious to claim "patient
>advocacy" when the behavoir of the CRSQA really stands for Lasik
>Advocacy.

Anyone who has read our website or reviewed my posts in this and other
forums knows that this and similar statements are nothing but bovine
fertilizer.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

2004-12-16, 9:25 am

Now is a good time to remind people that the 3% LASIK complication
rate refers to patients in their first 6 months post-op. During
these first months, some complications are expected. The 5% contact
lens complication rate refers to ALL contact lens wearers forever.

For instance... lets say we have 500 LASIK patients and 500 contact
lens wearers. Only 100 of those 500 LASIK patients are in their
first 6 months post op.. and of those 3% have complications... that
is 3 people... meanwhile 5% of the 500 contact lens wearers are
having complications... that is 25 people... hmmm... seems to me that
8 times as many contact lens wearers are suffering from complications
as lasik patiets.
With that said... 100% of people with vision problems who refuse to
wear contacts, glasses or have lasik suffer the complication of not
being able to see adequately! I know of somebody that fits in that
category.

Lastly, the 3% number is old. It's lower than that now.

On 8 Dec 2004 14:06:28 -0800, rebeccaNO_SPAM@lasermyeye.org wrote:

>Glenn, the 10% failure rate you are responding to here has nothing to
>do with the NICE report. It was reported by the Times originally in
>June 2003. Since then it has simply become a journalistic habit in the
>UK to use that warmed-over (and frankly confusing) statistic as filler
>in new reporting about laser eye surgery.

gospa68@aol.com

2004-12-16, 9:25 am

Glenn,
Despite what you say, your behavior stands, and provides clues as to
what you and the CRSQA are really up to.

I never intended to say whether or not you set the record straight,
that is for others to ascertain. Those who are familiar with your
postings would probably agree that you were trying to set the record
straight from your vested position, your point of view. You are
certainly welcomed to do that.

The real question is why you would take on the NHS of the UK, which has
the responsibility for patient welfare in the UK health system. They
have conducted their own independent study and have concluded that
LASIK is risky, that patients are not being properly informed, and that
long term complications are not being reported. I suspect that there
are many on this board that feel that this is not unique to the UK.
These problems exist in the US as well.

With regards to your testimony in Washington on phakic IOLs, it is
curious that you flew to Washington, at someone's (your
member's?)expense, to raise questions on this new category, while you
have never testified on concerns about LASIK, or any other laser
related procedure. Your sin of omission says loads about your intent.
WK

Glenn - USAEyes.org

2004-12-16, 9:25 am

>Lastly, the 3% number is old. It's lower than that now.

Yes, it is old, but the current rate is not lower. Fortunately, the
rate of serious complications seems to be creeping downward, but LASIK
induced dry eyes still remains at about the same as before, and that
is what keeps the rate up.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

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

2004-12-16, 9:25 am

>The real question is why you would take on the NHS of the UK, which has
>the responsibility for patient welfare in the UK health system.

I am not taking on the UK National Health System. I have responded to
what the British press is saying about a draft of an impending report.
What the NICE report actually says will not be known until it is
published on December 15th. My only comment regarding the NHS's
probable decision to not include LASIK is that I'm not surprised by
that position.

>They
>have conducted their own independent study and have concluded that
>LASIK is risky, that patients are not being properly informed,

You are making that up out of whole cloth. The report has not been
published, and the British press has not made this claim about the
contents of the draft report.

>and that
>long term complications are not being reported.

Again, this is not true. The british press has not stated that
complications are not being reported and the NICE report is not
published.

>I suspect that there
>are many on this board that feel that this is not unique to the UK.

I do not think people making up things to support their agenda is
unique to the UK either.

>With regards to your testimony in Washington on phakic IOLs, it is
>curious that you flew to Washington, at someone's (your
>member's?)expense, to raise questions on this new category, while you
>have never testified on concerns about LASIK, or any other laser
>related procedure. Your sin of omission says loads about your intent.

Yet another unresponsive response from WizKid. Again you have not
referenced one concern I raised at the meeting with a factual basis to
disagree. Instead, you complain that I was there, not what I said.

I have already responded to your accusation that there was some sort
of pro-LASIK, anti-P-IOL agenda. This is not true at all, but you
obviously have no desire to accept the truth.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

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

2004-12-16, 11:10 am

The UK's National Institute for Clinical Excellence (NICE) report has
been released. We responded with a press release in the UK that
raises our concerns with the manner and means of the report's
findings.

CRSQA Press Release
http://www.usaeyes.org/articles/UK_NICE_Response.pdf

NICE Press Release
http://www.usaeyes.org/articles/UK_NICE_Release.pdf

NICE Patient Booklet
http://www.usaeyes.org/articles/UK_NICE_Booklet.pdf

~~~~~~~~~~

FOR RELEASE DECEMBER 15, 2004, 00:01 GMT

HEADLINE - British Evaluation of LASIK Falls Short, Says Patient
Advocacy

SUMMARY SUBHEAD - National Institute for Clinical Excellence (NICE)
Provides More Confusion Than Answers, Ignores Current Technology.

SACRAMENTO - December 15, 2004 - An international patient advocacy
organization says the National Institute for Clinical Excellence
(NICE) interventional procedure guidance report of the popular laser
eye surgery LASIK is more likely to cause confusion than to help
advise patients and clinicians.

"The NICE report does not give the public information they need,
indicates problems where they are not necessarily a concern, ignores
areas of true concern, and does not reflect the current outcomes with
new advanced technology", states Glenn Hagele, Executive Director of
the California based Council for Refractive Surgery Quality Assurance
(www.USAEyes.org). "NICE has really performed a disservice to those
wanting to use LASIK to reduce their need for glasses or contacts."

LASIK, which is short for Laser Assisted In-situ Keratomileusis, uses
a laser to reshape the cornea to reduce or eliminate the need for
corrective lenses. The cornea is the clear front of the eye. Local
anesthetic is put into the person's eye at the start of the procedure.
A cutting instrument is used to create a flap in the cornea. The flap
is folded back so that the middle section of the cornea is exposed. A
laser is then used to remove a small amount of this middle section. A
computer controls the amount and where tissue is removed. When the
laser work is completed, the flap is folded back down into its
original position. It's kept in place by natural suction until it
heals. Approximately 8 million LASIK or similar laser eye surgery
procedures have been performed since introduction in the late 1980s,
with about 100,000 performed in the UK each year. LASIK is the most
often performed elective surgery in the world.

Based upon concerns raised during the yearlong investigation
culminating with the NICE report, The National Health System (NHS) has
declined to provide LASIK to UK citizens. Although the NHS has
declined to provide LASIK under its nationalized healthcare program,
the procedure is available though private clinics throughout the UK.
"It would be surprising for a federal or private health insurer to
provide expensive elective surgery like LASIK. LASIK treats a problem
that can normally be corrected with spectacles or contacts, which are
significantly less expensive and certainly less invasive than laser
eye surgery", says Hagele.

"One of the problems with the NICE report is that it does not reflect
current patient outcomes", says Hagele, whose organization evaluates
and certifies LASIK surgeons and provides patient information though
its Internet website. "They didn't include wavefront technology
lasers, which take a detailed and unique fingerprint of the patient's
eye and customize the laser treatment to maximize the probability of a
good outcome. By not including the outcomes of wavefront-guided
lasers, the NICE report was outdated before it was published."

The type and rate of complications from LASIK is an area where Hagele
believes the report causes substantial confusion. "Imprecise language
is used that does not provide a comprehensive answer to import
questions, such is the probability of having a permanent complication.
The report quotes rates of a few individual complications without
giving the big picture. Our organization has evaluated many medical
studies and reviewed thousands of LASIK patient outcomes. About three
percent of patients have some sort of unresolved complication at the
end of the normal six month healing period, with less than one-half of
one percent having a serious complication that requires extensive
maintenance or invasive intervention."

Even what constitutes a complication is unclear. "The NICE report
specifies incidents such as when cells get under the flap and
multiply, but this cell ingrowth is a problem can be readily resolved
with no long-term negative effect by lifting the flap and removing the
cells", reports Hagele. "There is a big difference between a problem
that is fully resolved, and a true long-term complication."

"Refractive surgery is often more of a six month process than a 20
minute miracle", says Hagele. "There are occasions when patients are
slightly over or undercorrected and this may require enhancement
surgery to 'fine tune' the result. Some patients may have a
significant improvement in vision, but not perfection and will require
glasses on occasion. Patients may experience dry eye, fluctuation in
vision, or similar temporary problems. In all but a relatively small,
but important, minority of cases, these issues are resolved with
healing or treatment."

"If to be considered a 'success' LASIK must provide instantly perfect
vision with no healing time, then somebody has unreasonable
expectations. This is surgery, after all, and surgery requires time
for healing."

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

Graeme Hewson

2004-12-16, 7:11 pm

Hi Glenn,

I've been lurking on this NG for a few months. I'm British, so
naturally I'm especially interested in the NICE report. I'm not sure it
tells me anything I don't already know, though. I'm considering
surgery, but steering towards LASEK. In your press release you pick up
on the imprecise language, and one thing I noticed in the report is the
lack of a definition of "moderate" myopia. Would you say that -3, or
thereabouts, is "moderate"? I also noticed that astigmatism was
practically unmentioned, and I would suspect that most people with
myopia also have astigmatism.

Have you, or has anyone else, managed to find an online copy of the
other report, written by members of Parliament (MPs) Frank Cook, Gwyneth
Dunwoody, and others, mentioned in the brief article in The Times at
http://www.timesonline.co.uk/articl...403509,00.html? The search
facility at http://www.parliament.uk is pretty dire...

Why is there such an emphasis on LASIK anyway -- why do LASEK and
other procedures barely get a mention? From the NICE report, to your
Web site, to the name of this NG, it's LASIK, LASIK, LASIK.

Incidentally, it's the National Health Service, not System, and I don't
know it's declined to provide LASIK to all UK citizens, since NICE
doesn't provide guidance to the NHS in Scotland or Northern Ireland,
only in England and Wales.
(http://news.bbc.co.uk/1/hi/health/2326095.stm)

Graeme Hewson

Glenn - USAEyes.org

2004-12-16, 7:11 pm

I think that most doctors would consider 3.00 diopters myopic
(nearsighted, shortsighted) moderate. Most see the breakpoint
somewhere between 6.00 and 8.00 diopters for myopia.

I am a fan of anything that reduces the possibility of a complication.
With a surface ablation technique like LASEK, PRK, or Epi-LASIK, there
is no stromal flap that can have complications in surgery or at some
time during the patient's life. No flap = No flap complications.

I don't have the report you seek, but I'll see what I can do to get a
copy. There will be a more comprehensive report in about a month.

LASIK has all the elements necessary in western society. Fast,
painless, and instant results. Well, that is what all those ads will
tell you. Other procedures are more invasive, have slower recovery,
and/or more discomfort. I would say this above all else is why
everyone talks about LASIK and little else.

We have all procedures up front on the home page, but most inquires
are about LASIK, most surgeries are LASIK, most refractive surgeons
perform LASIK, and so most information is about LASIK.

Thanks for the clarification on the language and jurisdiction.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

rebeccaNO_SPAM@lasermyeye.org

2004-12-21, 7:11 pm

Graeme Hewson wrote:

> I've been lurking on this NG for a few months. I'm British, so
> naturally I'm especially interested in the NICE report.

I've been trying to respond to this but I kept getting an error.
Graeme, if you would like to send me your email address I will email
the report to you.

Rebecca Petris
www.lasermyeye.org

rebeccaNO_SPAM@lasermyeye.org

2004-12-21, 7:11 pm

Graeme,

I'm sorry I didn't see this post earlier. If you send me an email I
will send you a copy of the report. I believe the press release
contained the email of the coordinator who can provide it, as well. I
had heard that it would not be available on the parliament.uk website
but would on another website, but I am not sure what website.

Regards,

Rebecca Petris
www.lasermyeye.org

p.s. I agree with you about the over-emphasis on LASIK. That is the
most popular procedure and that is what is widely promoted. - My
understanding of the reasons NICE reported specifically on LASIK (but
this is completely unofficial) is not so much the fact it is the most
used laser surgery as the fact that it is the most invasive. Much of
the focus was on complications which are unique to the LASIK flap and
depth of penetration.

rebeccaNO_SPAM@lasermyeye.org

2004-12-21, 7:11 pm

rebeccaNO_SPAM@lasermyeye.org

2004-12-21, 7:11 pm

Glenn - USAEyes.org

2004-12-22, 4:08 am

>Much of
>the focus was on complications which are unique to the LASIK flap and
>depth of penetration.

Yea, Complications relevant to technology and techniques of about a
decade ago.

Rebecca, what is your response to Dr. George Waring's public statement
that he is "appalled" that NICE used his study about surgeries
performed in 1995 and 1996 to evaluate LASIK, that this study is out
of date, and that its information "has essentially no bearing on
conditions of safety in 2004."

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

Graeme Hewson

2004-12-22, 7:11 pm

YHM

gospa68@aol.com

2004-12-23, 2:08 am

Greame,
LASIK probably gets the most press since it has been done more than any
other procedure and has been around longer. As such, LASIK would have
the greatest number of people who have suffered untoward outcomes.

A good paper on ALL procedures can be found at
http://www.lasikfraud.com/news/archives/000011.html

Some here, on this board, will dissuade you from reading it since it is
posted on lasikfraud. Do not let that be a deterrent. The NHS used it
as part of its background investigation. This article will give you a
good longitudinal view of refractive surgery, and the medical
publications/articles cited are recent and not on surgeries performed
in 1995 or 1996. The NHS assessment was not far from the mark.

You can expect those vested in LASIK to complain. They have made a
significant investment of money, time, and their reputations. They will
stand their ground as they have much to lose.

I like George Waring. but he is deeply vested in LASIK. George is the
one who introduced LASIK to the refractive community in 1997 at a
medical meeting (ESCRS)in Lisbon. He had just come from the Mid-East
where he had been performing it. Despite having absolutely no long term
data, he fully endorsed backing away from PRK, which had about 7 years
data at the time, and adopting LASIK.

I would encourage you to seriously consider LASEK, as you are. The flap
is the achilles heel of LASIK. This will become obvious to the public
with time.
WK

Dr. Leukoma

2004-12-23, 7:11 pm

Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in
news:p3eis0drhfbrl1h1cb911koev1nc7k49k0@4ax.com:

>
> Yea, Complications relevant to technology and techniques of about a
> decade ago.
>
> Rebecca, what is your response to Dr. George Waring's public statement
> that he is "appalled" that NICE used his study about surgeries
> performed in 1995 and 1996 to evaluate LASIK, that this study is out
> of date, and that its information "has essentially no bearing on
> conditions of safety in 2004."
>
> Glenn Hagele
> Executive Director
> Council for Refractive Surgery Quality Assurance
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
>

The same George Waring III who authored the PERK study (Prospective
Evaluation of Radial Keratotomy)? He should be clamboring for a PELASIK
study.

DrG

Glenn - USAEyes.org

2004-12-23, 10:08 pm

>The same George Waring III who authored the PERK study (Prospective
>Evaluation of Radial Keratotomy)? He should be clamboring for a PELASIK
>study.
>
>DrG

They are one and the same.

I've talked with George and others who would be obvious candidates to
create a LASIK study similar to PERK. This will probably never happen
for a number of reasons.

RK was very controversial at the time of the PERK study. Although
there are a few surgeons who today are against LASIK, at the time of
the PERK study the vast majority of ophthalmologists were against RK
and the anti-RK folks were being led by the American Academy of
Ophthalmology (AAO). In fact, a group of RK surgeons ended up suing
the AAO because of their anti-RK antics. The PERK study was needed to
demonstrate the safety and efficacy of RK.

I think the primary reason a LASIK study like PERK will not be created
is because it in effect already exists. PRK and later LASIK required
a medical device that was specifically approved by the FDA for that
purpose. RK required no such evaluation and had no such oversight.
In essence, all the FDA trials for approval of excimer lasers for PRK
and LASIK are the equivalent of a Prospective Evaluation of LASIK.

LASIK and other excimer laser assisted refractive surgery techniques
have already demonstrated a safety and efficacy that far surpasses RK.
There are significantly more studies already completed about LASIK and
PRK than all the RK studies combined. Add to that the FDA data, and
you have even more about PRK and LASIK than what the PERK study
provided about RK.

I would not go so far as to say a PERK study for LASIK is not needed,
but many argue that it would be redundant.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

Dr. Leukoma

2004-12-23, 10:08 pm

Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in
news:gfrms0t2rbh3kpji7l1jmlnptccnr28bnq@4ax.com:

>
> They are one and the same.
>
> I've talked with George and others who would be obvious candidates to
> create a LASIK study similar to PERK. This will probably never happen
> for a number of reasons.
>
> RK was very controversial at the time of the PERK study. Although
> there are a few surgeons who today are against LASIK, at the time of
> the PERK study the vast majority of ophthalmologists were against RK
> and the anti-RK folks were being led by the American Academy of
> Ophthalmology (AAO). In fact, a group of RK surgeons ended up suing
> the AAO because of their anti-RK antics. The PERK study was needed to
> demonstrate the safety and efficacy of RK.
>
> I think the primary reason a LASIK study like PERK will not be created
> is because it in effect already exists. PRK and later LASIK required
> a medical device that was specifically approved by the FDA for that
> purpose. RK required no such evaluation and had no such oversight.
> In essence, all the FDA trials for approval of excimer lasers for PRK
> and LASIK are the equivalent of a Prospective Evaluation of LASIK.
>
> LASIK and other excimer laser assisted refractive surgery techniques
> have already demonstrated a safety and efficacy that far surpasses RK.
> There are significantly more studies already completed about LASIK and
> PRK than all the RK studies combined. Add to that the FDA data, and
> you have even more about PRK and LASIK than what the PERK study
> provided about RK.
>
> I would not go so far as to say a PERK study for LASIK is not needed,
> but many argue that it would be redundant.
>
> Glenn Hagele
> Executive Director
> Council for Refractive Surgery Quality Assurance
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
>

These numerous but small studies remind me of some of the contact lens
safety studies of the 1980's, in which the purportedly "true" rate of eye
infections were extrapolated from hospital data.

Shouldn't a cosmetic surgery with the potential to affect tens of millions
of people be studied exhaustively? I would think that any government
agency in charge of healthcare financing would want to know the future
impact of such a surgery in terms of healthcare costs. I can't fault the
Brits for trying to do it. The next step will be taken by the insurance
industry, as they are the keepers of statistics.

DrG

Glenn - USAEyes.org

2004-12-23, 10:08 pm

I agree that many small studies are not as good as one grand study,
but what the FDA has required is really even more than what PERK
provided.

If you are referring to the UK's NICE study, IMO the Brits are not
trying to analyze refractive surgery as much as find an excuse not to
provide it under their national health plan.

You are right about insurance companies being excellent at determining
efficiency from a fiscal point of view (I once did this type of
analysis), but few insurance companies pay for LASIK and I doubt if
many ever will.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

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

I am not a doctor.

rebeccaNO_SPAM@lasermyeye.org

2004-12-23, 10:08 pm

> IMO the Brits are not
> trying to analyze refractive surgery as much as find an excuse not to
> provide it under their national health plan.

This is incorrect, for a number of reasons. And NICE and the NHS are
only part, and by no means the central part, of what "the Brits" are
doing with refractive surgery.

For a long time now, several members of parliament have been actively
interested in studying the relative safety of refractive surgery
practices in order to determine whether tighter regulation is needed. A
parliamentary panel was formed for this exclusive purpose. The views
they have taken - which were published on Dec 15th and include sweeping
recommendations for regulatory change in everything from advertising to
surgeon training standards and a lot in between - are the direct result
of the extensive testimony they heard last June and July from,
predominantly, current refractive surgeons.

I have been working with them for over a year and have been very
impressed with - and, even more, grateful for - their concern and
diligence. They are working to raise the bar. I can only hope that
other countries may follow their example.
Rebecca Petris
www.lasermyeye.org

Dr. Leukoma

2004-12-24, 2:08 am

Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in
news:c53ns0h9tl2ks1lseejb1icseenq3eujv4@4ax.com:

>
> You are right about insurance companies being excellent at determining
> efficiency from a fiscal point of view (I once did this type of
> analysis), but few insurance companies pay for LASIK and I doubt if
> many ever will.
>

'Never' is a long time. Anyway, I was primarily thinking of liability
carriers.

DrG