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Home > Archive > Lasik Eyes Surgery > November 2004 > Glenn Hagele, Patient Advocate, Testifies Against Phakic IOLs
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Glenn Hagele, Patient Advocate, Testifies Against Phakic IOLs
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| Wizkid 2004-11-02, 2:09 am |
| From NEWSDAY, November 2, 2004
EYE ON LASER ALTERNATIVE
IMPLANTABLE LENS IS A NEW VISION CORRECTION OPTION
Which option is the one for you?
BY DEBBE GEIGER
"...Approved by the Food and Drug Administration in September to
correct moderate to extreme nearsightedness, the Verisyse lens - which
will be marketed in the United States by Advanced Medical Optics of
Santa Ana, Calif. - is the first in the United States of a new class
of implantable ocular lenses that represent a significant advance in
vision correction surgery. Similar lenses are in clinical trials, with
another one expected to be approved shortly.
"You can take someone who is legally blind [without glasses], give
them these intraocular lenses, and get some of them to the point where
they can drive without glasses," said John Ciccone, director of
communications for the American Society of Cataract and Refractive
Surgery.
Brian Martin of Manchester, Conn., was one of those patients. At 45,
Martin had been wearing contact lenses for most of his life. "Without
them," he said, "I couldn't tell you how many fingers I was holding
up..."
According to GLENN HAGELE, executive director of the Council for
Refractive Surgery Quality Assurance, a nonprofit CONSUMER ADVOCACY
organization in Sacramento, the No. 1 issue is the skill of your
surgeon.
"This is not a procedure that a mediocre surgeon will do well. It's
going to be very important that the patient look at the practical
knowledge of their potential surgeon. The surgeon may not have
implanted this specific lens. It may be that a cataract surgeon will
have more skill with this particular surgery than a LASIK doctor,"
Hagele said.
Hagele testified at the FDA hearing about the concerns HIS GROUP
(Editorial note: LASIK surgeons or consumers?)had when the lens was
approved. He says that at some point the lens may have to be removed
and additional surgery performed either because the patient develops
cataracts or glaucoma as part of the normal aging process, or because
of some disruption caused by the lens. "The concern is that the
patients won't do the annual follow-up. This is not something they get
done once and go on their way. It needs to be evaluated on a regular
basis, because at some point it may need to come out."
Sounds pretty self-serving for Glenn's surgeon group...but then, this
is consistent with the what has gone on in refractive surgery since
day one. The patient loses....again.
WK
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| Sandy 2004-11-02, 11:14 am |
| > "You can take someone who is legally blind [without glasses], give
> them these intraocular lenses, and get some of them to the point where
> they can drive without glasses," said John Ciccone, director of
> communications for the American Society of Cataract and Refractive
> Surgery.
Wow, a pair of those miraculous gadgets called "contact lenses" can do
the same thing! Without surgery! How many of us are or were able to
read the 20/40 line without our glasses or contacts? I guess the
problem is that ophthalmologists don't profit from contact lenses and
that is why they need to come up with new and risky procedures to do
on unsuspecting "blind" people.
>
> Brian Martin of Manchester, Conn., was one of those patients. At 45,
> Martin had been wearing contact lenses for most of his life. "Without
> them," he said, "I couldn't tell you how many fingers I was holding
> up..."
That must mean that millions are candidates for this procedure. How
much is it?
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| Glenn - USAEyes.org 2004-11-02, 7:12 pm |
| Raising legitimate concerns that need to be considered is not
"testifying against" anything. Then again, it is not testifying for
anything either. It is simply providing the relevant facts so those
interested can make an informed decision.
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.
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| serebel 2004-11-02, 10:08 pm |
| sandy@savvysneaks.com (Sandy) wrote in message news:<1f704412.0411020705.430a7633@posting.google.com>...
>
> Wow, a pair of those miraculous gadgets called "contact lenses" can do
> the same thing! Without surgery! How many of us are or were able to
> read the 20/40 line without our glasses or contacts? I guess the
> problem is that ophthalmologists don't profit from contact lenses and
> that is why they need to come up with new and risky procedures to do
> on unsuspecting "blind" people.
>
>
> That must mean that millions are candidates for this procedure. How
> much is it?
Now you get it, nothing but conspiracies out there, but your'e not paranoid.
SErebel
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| Wizkid 2004-11-03, 2:08 am |
| Glenn, who are you trying to kid! Everyone knows that the risks of
LASIK increase with correction. Phakic IOLs are an excellent
alternative to LASIK for high myopes. Their approval follows years of
regulated testing...which LASIK did not.
Whose "legitimate concerns" were these? Your "groups"? If you are want
to air legitimate concerns, then start by being balanced and air those
that relate to LASIK too. Tell us when you will be in Washington next
to testify about "your groups" legitimate concerns relating to LASIK?
You are being disingenuous and duplicitous with both your words and
your actions. Why were you there? Why were you testifying? As a
patient advocate?...I think not and I am sure that others will see
through your charade.
Your agenda is becoming evident and it is contrary to being a patient
advocate. Like many others in this field, you have a vested interest
and it is not with the patient's welfare.
WK
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<nghfo0d3hosgg6ehekikqhcsq0aculbf17@4ax.com>...
> Raising legitimate concerns that need to be considered is not
> "testifying against" anything. Then again, it is not testifying for
> anything either. It is simply providing the relevant facts so those
> interested can make an informed decision.
>
> 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.
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| Glenn - USAEyes.org 2004-11-03, 7:12 pm |
|
>Glenn, who are you trying to kid! Everyone knows that the risks of
>LASIK increase with correction.
I have never suggested otherwise. One of the reasons wavefront-guided
ablations have had such great outcomes is that they are restricted to
myopes with a limited range of refractive error.
>Phakic IOLs are an excellent
>alternative to LASIK for high myopes.
For some patients under certain circumstances, P-IOLs are the most
appropriate refractive surgery technique, but "excellent" is a term I
would not use and P-IOLs are absolutely NOT an appropriate alternative
to LASIK for every patient.
Try to give me a straight answer on this one WizKid: How long can a
20 year old patient who has an endothelial cell count of 1800/mm2
safely have an Artisan/Verisyse phakic intraocular lens implanted,
considering that there are no other complications? Explain the
methodology behind your opinion.
> Their approval follows years of
>regulated testing...which LASIK did not.
Apparently in your rush to canonize P-IOLs you conveniently forgot all
the FDA regulated testing required for the current iteration of
excimer lasers, not to mention the scores of studies and reports from
around the world.
>Whose "legitimate concerns" were these? Your "groups"? If you are want
>to air legitimate concerns, then start by being balanced and air those
>that relate to LASIK too.
WizKid, I testified before the FDA Ophthalmic Devices Advisory Panel
that was evaluating the Artisan/Verisyse P-IOL. This was not an FDA
evaluation of LASIK and to discuss issues relating to other devices or
procedures would have been inappropriate.
> Tell us when you will be in Washington next
>to testify about "your groups" legitimate concerns relating to LASIK?
When the FDA has a hearing that relates to concerns regarding LASIK,
and my schedule/funding allows. I'll see you there.
>You are being disingenuous and duplicitous with both your words and
>your actions. Why were you there? Why were you testifying? As a
>patient advocate?...I think not and I am sure that others will see
>through your charade.
Why don't you simply read the transcript, it shows exactly the
concerns I raised.
http://www.fda.gov/ohrms/dockets/ac...ipts/4023t1.htm
My biggest worries about P-IOLs are the learning curve, continued loss
of endothelial cells (Artisan/Verisyse), trauma induced cataracts
(STAAR ICL), glaucoma, and the fact that patients are apparently not
being properly notified that P-IOLs are temporary.
>Your agenda is becoming evident and it is contrary to being a patient
>advocate.
This statement is laughable, especially coming from someone who rants
and raves with proclamations that he cannot substantiate.
>Like many others in this field, you have a vested interest
I have no vested interest whatsoever. I do not have ownership in any
device manufacturer. I am not a consultant to any manufacturer. Our
certification evaluates all procedures, including P-IOLs. The
information on our website and that I present is firmly grounded in
substantiated facts without regard to whose feet are stepped upon.
What is your vested interest in P-IOLs, WizKid? You don't even
identify yourself so others can evaluate what bias you may have.
>and it is not with the patient's welfare.
I guess we can let the patients look at the documentation and come to
their own conclusions about that.
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.
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| Wizkid 2004-11-05, 2:10 am |
| 1) When, if ever, were you in Washington raising concerns about PRK or
LASIK? I am not sure whrere you were when PRK was around, but I do
know you were around for LASIK. I do not remember you providing
testimony about the concerns people should have about either
procedure. Your record stands on its own - selective FDA testimony...
only on concerns with P-IOLs.
2) Who sits on your board? If you are a public interest group, why not
publicly disclose your financials? What does a surgeon pay for
certification? What is the breakdown of procedures done by your
certified members? What is the mix of lasers owned by your members?
How do you evaluate all procedures? What does a doctor have to do to
be decertified? How many have you decertified? That must be tough as
you lose the income...which makes you and your organization terribly
conflicted. Take the lead and provide us with complete disclosure,
then we will decide on whether or not you are conflicted.
I have no vested interest in refractive surgery. I do not earn a
living from refractive surgery in any form. I choose not to disclose
my identity here because I do not choose meet the same fate as Jeff
Machat. What happened to him was shameful. What he did in response was
shameful. I do not purport to be a patient advocate. I do, however,
advocate better and complete information to patients.
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| Glenn - USAEyes.org 2004-11-05, 2:10 am |
| We have not had unlimited funding to send someone to DC for every FDA
Ophthalmic Advisory Panel meeting, nor do CRSQA representatives have
unlimited availability. So far, I have testified in relation to
NearVision CK and the Artisan/Verisyse phakic intraocular lens.
Hopefully we will be able to do more in the future.
>2) Who sits on your board? .....
Why am I not surprised that you don't know the answers to these
questions. Perhaps you might consider visiting our website where all
this public information is available for anyone willing to look.
>I have no vested interest in refractive surgery. I do not earn a
>living from refractive surgery in any form. I choose not to disclose
>my identity here because I do not choose meet the same fate as Jeff
>Machat.
Of course you don't want your identity known. If peers saw the type
of foolishness you have perpetuated they would laugh you out of the
room. If I were you, I'd be guarding my identity as if my livelihood
depended on it. It just might.
Would any general doctor refer a patient to someone who they knew
makes such wild unfounded statements about ocular care as you do?
Gosh, I hope not.
> What happened to him was shameful. What he did in response was
>shameful.
Anyone who has been around the medical profession long enough knows
that they will devour their own if such circumstances arise. Dr.
Machat's situation is not exclusive to ophthalmology.
>I do not purport to be a patient advocate. I do, however,
>advocate better and complete information to patients.
Bovine fertilizer WizKid. When asked point-blank what you believe
would be a proper informed consent regarding ectasia, you respond with
nothing. When asked what you believe is the incidence of ectasia in
LASIK patients, you are silent. When asked about the incidence of
endothelial cell loss and its long-term ramification on a P-IOL
patient, you offer not a single word of "information".
If what you have propagated in this newsgroup is evidence of what you
believe patients need to see, then you desire nothing more than for
patients to be "informed" of unsubstantiated opinions about what may
happen someday that are totally counter to nearly five decades of
studies and millions of patients' practical experience. You don't
even exhibit the intestinal fortitude to make an attempt to justify
your uninformative rants.
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.
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| Wizkid 2004-11-06, 7:10 pm |
| As I suspected...all of your testimony is on non-laser based
procedures. And I will bet that all of your testimony focused on the
concerns of "your group." As stated earlier, you are no patient
advocate. You represent a group with a vested financial interest. WK
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<2s5io0h9sftl7aq8lg61fqkm2k1ljfae8r@4ax.com>...
"So far, I have testified in relation to
NearVision CK and the Artisan/Verisyse phakic intraocular lens.
Hopefully we will be able to do more in the future."
| |
| Glenn - USAEyes.org 2004-11-06, 7:10 pm |
| You are really becoming quite laughable, WizKid.
These were the first FDA-ODP instances where we had both the resources
for me to make the trip possible, and the concerns that warranted the
testimony.
Your suggestion that I am somehow pro-laser ignores not only the
objective information that we provide on all refractive surgery
techniques, but my long history of support for Intacs as a viable
alternative to LASIK and even PRK for low myopes. The industry has
not gone that direction, but if you look at my history you will see
that I did what I could to inform patients of this alternative.
Equally, we have provided similar amounts of information on lens-based
surgery such as Refractive Lens Exchange, including the new CrystaLens
accommodating intraocular lens.
We are not going to ignore the very real limits of P-IOLs just because
you think they are the greatest thing since sliced bread.
And now for the umpteenth time, how about some answers to these simple
questions that someone who has presented himself as such an expert
should be able to answer quite readily:
What to you believe to be the safe minimum untouched cornea after
LASIK required in a healthy eye?
How long can a 20-year-old patient who has an endothelial cell count
of 1800/mm2 safely have an Artisan/Verisyse phakic intraocular lens
implanted, considering that there are no other complications?
What information do you believe a patient needs to review before
successfully completing an informed consent process for LASIK and can
make an informed decision?
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.
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| Wizkid 2004-11-07, 7:11 pm |
| CRSQA may provide information on other procedures but according to
your website, you only certify and recommend LASIK surgeons. This has
the appearance of being a significant conflict-of-interest. You are
financed by those who do LASIK procedures. You only certify those who
do LASIK procedures. You testify only on concerns related to non-LASIK
procedures. What else does the public need to know?
From you website...
"Evaluated LASIK Surgeons Don't settle for just any eye surgeon. No
amount of technology can compensate for an inferior surgeon. LASIK
may be considered very safe and successful, but the quality of the
surgeon is of primary importance. We recommend a CRSQA Certified
LASIK Laser Eye Surgeon or use our 50 Tough Questions For Your LASIK
Doctor to help evaluate an uncertified LASIK surgeon."
WK
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| Glenn - USAEyes.org 2004-11-07, 7:11 pm |
| >CRSQA may provide information on other procedures but according to
>your website, you only certify and recommend LASIK surgeons.
You are absolutely and totally wrong yet again. We certify refractive
surgeons. All refractive surgery techniques are included in our
evaluation.
Give it a break WizKid. I've been doing this for the better part of
five years. I know what our organization does.
>From you website...
>"Evaluated LASIK Surgeons
Yes, they are LASIK surgeons and we use the keyword LASIK very often
throughout our website because LASIK is what people know and LASIK is
what the majority of people search. Once they are at our website
because of a "LASIK" keyword Internet search, they can learn about all
the relevant refractive surgery procedures. We also have the term
"refractive surgeon" all over the website, but to a lesser degree than
LASIK. The same with PRK, RLE, Intralase, P-IOL, CrystaLens, on and
on. They are all there.
Again, how about some answers to these simple questions that someone
who has presented himself as such an expert should be able to answer
quite readily:
1) What to you believe to be the safe minimum untouched cornea after
LASIK required in a healthy eye?
2) How long can a 20-year-old patient who has an endothelial cell
count of 1800/mm2 safely have an Artisan/Verisyse phakic intraocular
lens implanted, considering that there are no other complications?
3) What information do you believe a patient needs to review before
successfully completing an informed consent process for LASIK and can
make an informed decision?
I'm beginning to believe that you really cannot answer a question
factually. The only thing you have offered up in this newsgroup is
your unsubstantiated opinion and accusations about me or the group I
represent.
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.
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