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More on Intacs...background on the manufacturer, Addition Technologies
|
|
| Wizkid 2004-10-30, 11:08 am |
| OCULAR SURGERY NEWS 10/15/2004
Specialty device companies fill niches in ophthalmology
Small device companies assume risks that bigger companies avoid to
bring innovation to ophthalmogy, one analyst said. Kim Norton
Addition Technology
Addition Technology's signature product is the Intacs prescription
corneal insert, which was developed in the 1980s and '90s by the
now-defunct KeraVision. Intacs is currently the only device of its
kind approved by the Food and Drug Administration. The device is
approved for correction of myopia of up to 3 D, and it can also be
used under a humanitarian device exemption for treatment of
keratoconus.
The company is investigating the feasibility of using the insert for
other conditions, explained William Flynn, chief executive officer of
Addition Technology. Research is ongoing in formal clinical
evaluations in the United States and internationally, he said.
Addition, which is not publicly traded, intends to remain a niche
therapeutic company within eye care, Mr. Flynn said. The company has
no licensing agreements with other companies and no plans to enter
into any, he said.
"We are going to try to stay with similar products in the future,
although we have nothing in our pipeline currently," Mr. Flynn said.
"We have had discussions with various companies regarding expansion,
but nothing that has come to fruition. We are focused on ophthalmology
because that is where our comfort zone lies, and the majority of the
company has a strong background in it."
| |
|
| Intacs are also being used to treat post-LASIK bulging of the
surgically thinned corneas, known as ectasia.
| |
|
| Well.. a few comments here. The Intacs company is bankrupt, but they
still make them. They are very rarely used. Their effectiveness is
questionable. They are used to treat ectasia no matter what the
cause. Ecstasia happens. It's not something unique to post LASIK
patients.
Here's something to consider. In LASIK, no tissue is removed beyond
50% of the depth of the cornea, and the flap which is about 25% of the
depth gradually heals on top of that 50%. In RK, the incisions to
cause bulging must be made between 95% and 98% of the depth of the
cornea to get it to bulge.
The reader can draw their own conclusions.
On 30 Oct 2004 22:27:44 -0700, sandy@savvysneaks.com (Sandy) wrote:
>Intacs are also being used to treat post-LASIK bulging of the
>surgically thinned corneas, known as ectasia.
| |
| Glenn - USAEyes.org 2004-10-31, 7:11 pm |
| The original manufacturer of Intacs was liquidated and its assets were
purchased by a new privately held company, Addition Technology, who
currently manufacturers the product.
I recently discussed Intacs with Addition Technology representatives
and they find that over 90% of Intacs implanted today are for the
therapeutic treatment of keratoconus or ectasia.
In addition to RM's points regarding the stability of the cornea after
LASIK, the components of LASIK are not new and have been around for
the better part of 50 years. The effects of a corneal flap for
refractive and transplant purposes is not new and the long-term
efficacy has been firmly established.
Although there have been case studies of LASIK patients who should
have had more than 250 microns of untouched corneal tissue developing
ectasia, one by one these are being defined as the consequence of
something not previously diagnosed. The two primary problems that
have been found to have caused the ectasia are a flap thickness that
was significantly different than predicted and/or the undiagnosed
presence of preoperative keratoconus.
Keratoconus is a forward bulging of the lower portion of the cornea
due to a chronic and often progressive weakness of the corneal tissue.
Keratoconus occurs naturally and is not caused by LASIK or other
refractive surgery, however refractive surgery can exacerbate the
situation and accelerate the bulging.
It is important to note that those who are crying that the ectasia sky
is falling have not provided one single study in all the years of
lamellar surgery to substantiate their claims of gloom and doom. If
the health of the eye is properly determined and the rules of tissue
removal are followed, ectasia is not a problem.
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.
| |
| Wizkid 2004-10-31, 7:11 pm |
| You are quite uninformed. The "Intacs company" is alive and thriving.
A group of investors, the former executive team of Wesley Jessen
(which was acquired by Ciba in 2001, bought the assets of KeraVision
and reorganized it as Addition Technologies. The company is privately
held and is not bankrupt. From what my sources tell me, they are now
profitable and revenue growth is substantial.
Iatrogenic ectasia (post-LASIK ectasia) does not just happened. It is
induced. Apparently, you have not taken the time to understand the
mechanics and the strucuture of the cornea. I encourage you to do so.
Once you have become acquainted with the underlying science, you will
grasp the nature and seriousness of ectasia. WK
RM <rm@yahoo.com> wrote in message news:<e5f9o0t3bha3rlq6osi4nc934m96l4o0uf@4ax.com>...[vbcol=seagreen]
> Well.. a few comments here. The Intacs company is bankrupt, but they
> still make them. They are very rarely used. Their effectiveness is
> questionable. They are used to treat ectasia no matter what the
> cause. Ecstasia happens. It's not something unique to post LASIK
> patients.
> Here's something to consider. In LASIK, no tissue is removed beyond
> 50% of the depth of the cornea, and the flap which is about 25% of the
> depth gradually heals on top of that 50%. In RK, the incisions to
> cause bulging must be made between 95% and 98% of the depth of the
> cornea to get it to bulge.
> The reader can draw their own conclusions.
>
>
> On 30 Oct 2004 22:27:44 -0700, sandy@savvysneaks.com (Sandy) wrote:
>
| |
| Bill Trattler, MD 2004-10-31, 10:08 pm |
| " If
> the health of the eye is properly determined and the rules of tissue
> removal are followed, ectasia is not a problem."
>
> Glenn Hagele
Glenn,
I am sure you are aware of the cases where the preoperative
topographies were 100% normal and the "250 micron bed" was respected -
yet ectasia occurred. RAndy Epstein,MD, from Chicago Cornea
Associates, has put together 11 such cases (including 2 from our
center)where the preoperative signs were normal and the ablation
depths were low - yet ectasia occurred. In one of my cases, we also
went back via confocal to measure the actual flap depth. The residual
stromal bed was over 290 microns.
The real point is that there is a tiny subset of patients who have
an underlying condition that is pre-Forme-Fruste keratoconus. That
means - that over time, they will develop signs of Forme-Fruste
Keratoconus - but at the time of their evaluation - their topographies
and Orbscans are normal. A great example is when we see a patient
with Forme-Fruste keratoconus in one eye and a 100% normal appearing
cornea in the other eye. The topo and orbscan both show that the
second eye appears normal. But if you follow that second eye over
time, it will eventually develop signs of Forme-Fruste keratoconus. As
well, if you were to perform LASIK on these eyes, both eyes would end
up with ectasia.
Clearly - this is a tiny subset of the population. Although we
had 2 such cases in the first 3000 cases at our center, I know that
other centers have had a much lower rate.
Of course - the vast majority of ectasia cases that I have seen
are related to poor patient selection. Patient selection appears to
have improved. As well, perhaps Intralase-based LASIK will allow for
the rate of ectasia to drop further. I personally have steered
towards LASEK, since there is no flap, and that has helped me avoid
further cases of ectasia.
I hope this helps
Bill Trattler, MD
Miami, FL
| |
| Ragnar Suomi 2004-11-01, 2:09 am |
| Ecstasia occurs in people who never had LASIK. It would be
interesting to compare rates of ecstasia of moderate to severe myopes
who had LASIK with moderate to severe myopes that did not have LASIK.
On 31 Oct 2004 19:09:55 -0800, wtrattler@earthlink.net (Bill Trattler,
MD) wrote:
>" If
>
>Glenn,
> I am sure you are aware of the cases where the preoperative
>topographies were 100% normal and the "250 micron bed" was respected -
>yet ectasia occurred. RAndy Epstein,MD, from Chicago Cornea
>Associates, has put together 11 such cases (including 2 from our
>center)where the preoperative signs were normal and the ablation
>depths were low - yet ectasia occurred. In one of my cases, we also
>went back via confocal to measure the actual flap depth. The residual
>stromal bed was over 290 microns.
> The real point is that there is a tiny subset of patients who have
>an underlying condition that is pre-Forme-Fruste keratoconus. That
>means - that over time, they will develop signs of Forme-Fruste
>Keratoconus - but at the time of their evaluation - their topographies
>and Orbscans are normal. A great example is when we see a patient
>with Forme-Fruste keratoconus in one eye and a 100% normal appearing
>cornea in the other eye. The topo and orbscan both show that the
>second eye appears normal. But if you follow that second eye over
>time, it will eventually develop signs of Forme-Fruste keratoconus. As
>well, if you were to perform LASIK on these eyes, both eyes would end
>up with ectasia.
> Clearly - this is a tiny subset of the population. Although we
>had 2 such cases in the first 3000 cases at our center, I know that
>other centers have had a much lower rate.
> Of course - the vast majority of ectasia cases that I have seen
>are related to poor patient selection. Patient selection appears to
>have improved. As well, perhaps Intralase-based LASIK will allow for
>the rate of ectasia to drop further. I personally have steered
>towards LASEK, since there is no flap, and that has helped me avoid
>further cases of ectasia.
>
>I hope this helps
>
>Bill Trattler, MD
>Miami, FL
| |
| Glenn - USAEyes.org 2004-11-01, 2:10 am |
| I agree Bill, those cases with underlying disease such as Forme-Fruste
keratoconus do not have healthy corneas. I stated that a healthy
cornea with 250 microns untouched should not be a problem. This has
been established over decades and is codified in the approvals (of
course more is always better). All bets are off with a diseased
cornea.
The fact that Forme-Fruste keratoconus is sometimes not diagnosed
prior to refractive surgery is a very real concern, but as you noted
it is in a tiny subset of patients.
You've read the posts. Do YOU think ectasia is the massive problem
that WizKid has presented it to be? You are reporting an incidence of
0.06% Forme-Fruste developing into ectasia in your first 3,000
patients and other clinics having a lower rate. Do you think this
kind of incidence warrants WizKid's proclamations in this forum?
In any event, I concur with the wisdom of moving toward surface
ablation when possible. There is significantly more untouched cornea
and never the possibility of a LASIK flap related complication during
surgery or at any time in the patient's life. The Intralase
femtosecond laser flap when LASIK is indicated does provide a higher
degree of accuracy than a mechanical microkeratome and would make the
probability of accidently ablating under the 250 micron minimum less
likely.
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, you are suffering from a serious and disturbing case of denial.
Cases of post-lasik ectasia in patients with well over 250 microns of
RSB have been posted to this newsgroup and on other websites you
frequent.
>
> It is important to note that those who are crying that the ectasia sky
> is falling have not provided one single study in all the years of
> lamellar surgery to substantiate their claims of gloom and doom. If
> the health of the eye is properly determined and the rules of tissue
> removal are followed, ectasia is not a problem.
>
> 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.
| |
| Rebecca 2004-11-01, 11:09 am |
| wtrattler@earthlink.net (Bill Trattler, MD) wrote in message news:<1cccea40.0410311909.7ab3aca@posting.google.com>...
> " If
>
> Glenn,
> I am sure you are aware of the cases where the preoperative
> topographies were 100% normal and the "250 micron bed" was respected -
> yet ectasia occurred. RAndy Epstein,MD, from Chicago Cornea
> Associates, has put together 11 such cases (including 2 from our
> center)where the preoperative signs were normal and the ablation
> depths were low - yet ectasia occurred. In one of my cases, we also
> went back via confocal to measure the actual flap depth. The residual
> stromal bed was over 290 microns.
> The real point is that there is a tiny subset of patients who have
> an underlying condition that is pre-Forme-Fruste keratoconus. That
> means - that over time, they will develop signs of Forme-Fruste
> Keratoconus - but at the time of their evaluation - their topographies
> and Orbscans are normal. A great example is when we see a patient
> with Forme-Fruste keratoconus in one eye and a 100% normal appearing
> cornea in the other eye. The topo and orbscan both show that the
> second eye appears normal. But if you follow that second eye over
> time, it will eventually develop signs of Forme-Fruste keratoconus. As
> well, if you were to perform LASIK on these eyes, both eyes would end
> up with ectasia.
> Clearly - this is a tiny subset of the population. Although we
> had 2 such cases in the first 3000 cases at our center, I know that
> other centers have had a much lower rate.
> Of course - the vast majority of ectasia cases that I have seen
> are related to poor patient selection. Patient selection appears to
> have improved. As well, perhaps Intralase-based LASIK will allow for
> the rate of ectasia to drop further. I personally have steered
> towards LASEK, since there is no flap, and that has helped me avoid
> further cases of ectasia.
>
> I hope this helps
>
> Bill Trattler, MD
> Miami, FL
This is a very interesting discussion.
I have tended to think of ectasia cases as mostly falling into two
categories:
1) Poor patient selection by any reasonable standards, i.e.
out-and-out failure to perform pre-operative topography or failure to
identify clearn signs of KC or FFKC; and
2) Poor patient selection "in retrospect". What I mean by this is,
pre-op analysis of topographies is becoming more sophisticated over
time in response to widespread ectasia problems and I've noticed that
in many cases what one doctor thinks is a normal cornea another doctor
identifies as abnormal. I have heard many discussions recently about
specific techniques for identifying patients whose topographies appear
perfectly normal but who nevertheless may be higher risk for ectasia.
If I understand correctly there is a small third category, where there
is no risk factor yet identifiable. Perhaps over time some common
thread will become more apparent. I myself am very interested in the
views I've heard from Dr Kanellopoulos about the possibility of
keratoconus being perhaps a wider spectrum disease than is presently
understood.
At any rate whether ectasia is primarily, or exclusively, a screening
issue or no is no doubt a very interesting question medically
speaking. But where such a very serious condition is concerned, with
such poor prospects for those who do get it, it is the incidence and
not the causation that matter most to the patients. Attributing cases
to poor screening in no way lessens the seriousness of their
occurrence or the dilemma, for the patient, in evaluating the risk. It
is simply that the risk may be a risk of screening or may be a risk of
poor equipment function (microkeratome inaccuracy) or may be a purely
random risk. From the patient's perspective, it almost doesn't matter,
because it is something over which the patient does not have control.
| |
| Glenn - USAEyes.org 2004-11-01, 7:12 pm |
| >Attributing cases
>to poor screening in no way lessens the seriousness of their
>occurrence or the dilemma, for the patient, in evaluating the risk.
If anything, the fact that poor screening is a contributing factor
increases the seriousness. Even if the occurrence of LASIK related
ectasia is less than 3/5ths of one percent, the fact that proper
screening may prevent a bad outcome reaffirms the need to carefully
select a prospective surgeon.
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 2004-11-01, 7:12 pm |
|
>Cases of post-lasik ectasia in patients with well over 250 microns of
>RSB have been posted to this newsgroup and on other websites you
>frequent.
Continued analysis has shown time and again that either the flap
thickness was not as previously expected and the patient actually had
less than 250 microns of untouched cornea, and/or naturally occurring
keratoconus was previously undiagnosed.
There are a few cases that have not yet yielded a clear explanation as
to cause, but they are so few as to be statistically suspect. As Dr.
Trattler pointed out with his own patients, the overall occurrence is
less than 0.06%. The unexplained/undiagnosed rate is even less.
Ectasia, although certainly undesired, is an effect that tends to
stabilize. The patient may not get the desired "throw away your
glasses" effect, but fortunately the net effect of ectasia is often
that the patient remains myopic with no other vision health problems.
For those with more extensive difficulties, ectasia is often
manageable with rigid contacts, collagen crosslinking stabilization,
Intacs, or in a worst case scenario; corneal transplants.
Fortunately for the 0.06% or fewer who are affected, there are options
and treatments.
Refractive surgery is not perfect. Surgeons are not perfect. There
is risk with any surgery and LASIK is no exception. If someone is not
willing to accept any level of risk and demands perfect outcomes for
every patient every time, then that person should not have any surgery
of any kind...most certainly not an elective surgery such as LASIK.
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.
| |
| Wizkid 2004-11-02, 2:09 am |
| Glenn did you attend this session at the ESCRS in Paris in September?
INSTRUCTIONAL COURSE ON COMPLICATIONS PREVENTION AND MANAGEMENT
This was course run by a panel consiting of Dr Michael Assouline, Dr
Nico Trap, Dr Jerry Tan, Dr John Kanellopoulos, and Dr Sheraz Daya.
Screening for ECTASIA was discussed at great length, and comments
about or examples of ectasia came up repeatedly throughout the
session. During the pre-operative screening part, many opinions were
shared about how to identify the borderline cases. Considerable
emphasis was placed on Orbscan and attendees were encouraged to buy
one if they didn't already have one.
There was an interesting discussion about "whether we are creating an
ectasia time bomb with the forme fruste keratoconus patients" and an
acknowledgement that THIS MIGHT BE THE CASE. There was considerable
discussion about how much stroma to leave. Dr Kanellopoulos stated
that he always leaves 280um under the flap. Another doctor commented
that if he does that he "MUST TURN AWAY AN AWFUL LOT OF PATIENTS". He
said no, he simply does a smaller zone on the basis that HE'D RATHER
HIS PATIENT HAVE NVD THAN ECTASIA – but he discusses it all up front
with the patient and leaves it up to the patient to decide whether to
proceed with surgery.
WK
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<qutco01hs6ogrlgbccqtbt5sks0rstovt5@4ax.com>...
>
> Continued analysis has shown time and again that either the flap
> thickness was not as previously expected and the patient actually had
> less than 250 microns of untouched cornea, and/or naturally occurring
> keratoconus was previously undiagnosed.
>
> There are a few cases that have not yet yielded a clear explanation as
> to cause, but they are so few as to be statistically suspect. As Dr.
> Trattler pointed out with his own patients, the overall occurrence is
> less than 0.06%. The unexplained/undiagnosed rate is even less.
>
> Ectasia, although certainly undesired, is an effect that tends to
> stabilize. The patient may not get the desired "throw away your
> glasses" effect, but fortunately the net effect of ectasia is often
> that the patient remains myopic with no other vision health problems.
> For those with more extensive difficulties, ectasia is often
> manageable with rigid contacts, collagen crosslinking stabilization,
> Intacs, or in a worst case scenario; corneal transplants.
>
> Fortunately for the 0.06% or fewer who are affected, there are options
> and treatments.
>
> Refractive surgery is not perfect. Surgeons are not perfect. There
> is risk with any surgery and LASIK is no exception. If someone is not
> willing to accept any level of risk and demands perfect outcomes for
> every patient every time, then that person should not have any surgery
> of any kind...most certainly not an elective surgery such as LASIK.
>
> 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.
| |
|
| In article <c11e3ecf.0411012156.7f5c81c@posting.google.com>,
gospa68@aol.com (Wizkid) wrote:
> There was an interesting discussion about "whether we are creating an
> ectasia time bomb with the forme fruste keratoconus patients"
How common is this condition? Isn't it something patients are screened
for? Could a patient have it and not know it? Is that why you are
posting so much about this?
| |
| Glenn - USAEyes.org 2004-11-02, 7:12 pm |
| No, I attended a different course at that time period, but I am
familiar with all the issues that you have noted and they support my
position that I have put forward here many times.
1) Ectasia does occur, but very rarely. One accomplished refractive
surgeon has reported in this newsgroup an incidence of 0.06% based
upon his first 3,000 patients.
2) Lamellar surgery has been around for about 50 years and its effects
and limitations are well understood and documented.
3) Ectasia does not occur if the eye is healthy and at least 250
microns of corneal tissue are left untouched.
4) There are a handfuls of ectasia cases that exist that are not
explained by disease or thin cornea, however they are so few as to be
statistically suspect.
5) Proper screening of a patient for disease, corneal thickness, flap
thickness, amount of tissue to be ablated, etc. are required and all
need to be evaluated by a competent surgeon before any patient should
have LASIK or similar surgery. The current extremely low rate of
ectasia indicates that, for the most part, this does occur.
6) If ectasia does occur it tends be stable, allowing treatment or
accommodation with contacts, glasses, collagen crosslinking, or simply
being a bit nearsighted.
7) WizKid makes all these grand pronouncements about ectasia being
some sort of public health problem, but has provided not one single
study, peer reviewed or otherwise, to substantiate his ridiculous
claims. Just aspersions that someday something might happen. We have
had about 50 years of somedays and what happens happens around 3/50th
of one percent of the time.
8) Why WizKid is attempting to create the appearance of a problem that
does not exist in the form or frequency he suggests is open to
interpretation of WizKid's motivation.
9) Anyone who buys in to WizKid's gloom and doom can consider
alternatives such as PRK, LASEK, Epi-LASIK, Intacs, Refractive Lens
Exchange, Phakic Intraocular Lenses, Orthokeratology, contacts, and
glasses.
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.
| |
| Rebecca 2004-11-02, 7:12 pm |
| RT <RTMD24@NOSPAMyahoo.com> wrote in message news:<RTMD24-41D0C3.07233402112004@newssvr13-ext.news.prodigy.com>...
> How common is this condition? Isn't it something patients are screened
> for? Could a patient have it and not know it? Is that why you are
> posting so much about this?
Yes, they are screened (usually - actually, according to the surveys
many clinics do not do post-operative topography at all and many more
do not use Orbscan, which is probably the best tool for FFKC
screening) but this is not nearly as straightforward as a simple
measurement such as corneal thickness. To detect borderline cases it
may require extensive experience.
It's very UNlikely a patient with FFKC would know it.
One of the possibilities I have heard floated by ophthalmologists who
have studied this in depth is that keratoconus, which is not a well
understood condition, may be a much wider spectrum disease than
currently thought to be, the milder forms of which are not detectable
with current analysis techniques.
| |
| serebel 2004-11-02, 10:08 pm |
| RT <RTMD24@NOSPAMyahoo.com> wrote in message news:<RTMD24-41D0C3.07233402112004@newssvr13-ext.news.prodigy.com>...
> In article <c11e3ecf.0411012156.7f5c81c@posting.google.com>,
> gospa68@aol.com (Wizkid) wrote:
>
>
> How common is this condition? Isn't it something patients are screened
> for? Could a patient have it and not know it? Is that why you are
> posting so much about this?
RT,
Don't fall for this chicken little b.s., You have a better chance of
getting hit by lightning.
SErebel
| |
| Wizkid 2004-11-03, 2:08 am |
| You did not attend the course and it is clear that you are not
following the literature either. Read Binder's comments below slowly
so you can absorb them..."The current literature is UNABLE to define a
specific residual corneal thickness or a range of preoperative corneal
thickness that would put an eye at risk for developing ectasia...Other
as yet undetemined factors..." If you are going to be a patient
advocate, you can start by getting the facts straight. WK
ECATSIA AFER LASER IN SITU KERATOMILEUSIS (Journal of Cataract and
Refractive Surgery, December 2003)
Binder PS.
Gordon Binder Vision Institute, San Diego, CA 92112, USA.
garrett23@aol.com
Eighty-five cases of post laser in situ keratomileusis ectasia were
reviewed and analyzed. Cases of keratoconus or forme fruste
keratoconus were eliminated; many remaining case reports lacked key
information. The current literature is unable to define a specific
residual corneal thickness or a range of preoperative corneal
thickness that would put an eye at risk for developing ectasia. The
most logical cause for eyes without preexisting pathology to develop
ectasia is a postablation stromal thickness that is mechanically
unstable; this "minimal" thickness is probably specific to each eye.
The preoperative and postoperative corneal thickness, measured flap
thickness, and microkeratome and laser parameters used in a given case
are required to determine the range of residual corneal thickness that
puts the eye at risk for developing ectasia. OTHER AS YET UNDETERMINED
FACTORS MAY PLAY A ROLE in the development of this complication.
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<1vefo0hic151jj4r7b8na5231gvderbler@4ax.com>...
> No, I attended a different course at that time period, but I am
> familiar with all the issues that you have noted and they support my
> position that I have put forward here many times.
>
> 1) Ectasia does occur, but very rarely. One accomplished refractive
> surgeon has reported in this newsgroup an incidence of 0.06% based
> upon his first 3,000 patients.
>
> 2) Lamellar surgery has been around for about 50 years and its effects
> and limitations are well understood and documented.
>
> 3) Ectasia does not occur if the eye is healthy and at least 250
> microns of corneal tissue are left untouched.
>
> 4) There are a handfuls of ectasia cases that exist that are not
> explained by disease or thin cornea, however they are so few as to be
> statistically suspect.
>
> 5) Proper screening of a patient for disease, corneal thickness, flap
> thickness, amount of tissue to be ablated, etc. are required and all
> need to be evaluated by a competent surgeon before any patient should
> have LASIK or similar surgery. The current extremely low rate of
> ectasia indicates that, for the most part, this does occur.
>
> 6) If ectasia does occur it tends be stable, allowing treatment or
> accommodation with contacts, glasses, collagen crosslinking, or simply
> being a bit nearsighted.
>
> 7) WizKid makes all these grand pronouncements about ectasia being
> some sort of public health problem, but has provided not one single
> study, peer reviewed or otherwise, to substantiate his ridiculous
> claims. Just aspersions that someday something might happen. We have
> had about 50 years of somedays and what happens happens around 3/50th
> of one percent of the time.
>
> 8) Why WizKid is attempting to create the appearance of a problem that
> does not exist in the form or frequency he suggests is open to
> interpretation of WizKid's motivation.
>
> 9) Anyone who buys in to WizKid's gloom and doom can consider
> alternatives such as PRK, LASEK, Epi-LASIK, Intacs, Refractive Lens
> Exchange, Phakic Intraocular Lenses, Orthokeratology, contacts, and
> glasses.
>
> 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.
| |
|
| In article <120ffab4.0411021439.5f5b61ee@posting.google.com>,
rebeccaNO_SPAM@lasermyeye.org (Rebecca) wrote:
> RT <RTMD24@NOSPAMyahoo.com> wrote in message
> news:<RTMD24-41D0C3.07233402112004@newssvr13-ext.news.prodigy.com>...
>
>
>
> Yes, they are screened (usually - actually, according to the surveys
> many clinics do not do post-operative topography at all and many more
> do not use Orbscan, which is probably the best tool for FFKC
> screening) but this is not nearly as straightforward as a simple
> measurement such as corneal thickness. To detect borderline cases it
> may require extensive experience.
>
> It's very UNlikely a patient with FFKC would know it.
>
> One of the possibilities I have heard floated by ophthalmologists who
> have studied this in depth is that keratoconus, which is not a well
> understood condition, may be a much wider spectrum disease than
> currently thought to be, the milder forms of which are not detectable
> with current analysis techniques.
thanks rebecca
| |
|
| In article <6ddf3bb5.0411021758.2722b6a9@posting.google.com>,
serebel@aol.com (serebel) wrote:
>
> RT,
> Don't fall for this chicken little b.s., You have a better chance of
> getting hit by lightning.
>
> SErebel
well, then it may be more like my chances of being hit by a meteorite,
which my son informs me is 4x more likely than lightning
Seriously though, I don't think being aware of possibilities is
practicing chicken little. I've always been concerned about the
relative infancy of this procedure and whether or not there may be
things to look out for in the long term. I had never heard about
ecstasia before reading this group post-LASIK. If a potential LASIK
patient is armed with this info pre-procedure all the better for
her/him. That's why I wanted to know about how common it is and whether
or not a person may know or not. It's a good thing for those
researching LASIK to know NOT to opt for the procedure anyway (by not
disclosing this condition to the surgeon perhaps if its not detected
during the screening). Obviously it would be a contra-indication.
| |
| Dr. Leukoma 2004-11-03, 11:10 am |
| RT <RTMD24@NOSPAMyahoo.com> wrote in
news:RTMD24-A5DD59.07382303112004@newssvr13-ext.news.prodigy.com:
> In article <6ddf3bb5.0411021758.2722b6a9@posting.google.com>,
> serebel@aol.com (serebel) wrote:
>
>
> well, then it may be more like my chances of being hit by a meteorite,
> which my son informs me is 4x more likely than lightning
>
> Seriously though, I don't think being aware of possibilities is
> practicing chicken little. I've always been concerned about the
> relative infancy of this procedure and whether or not there may be
> things to look out for in the long term. I had never heard about
> ecstasia before reading this group post-LASIK. If a potential LASIK
> patient is armed with this info pre-procedure all the better for
> her/him. That's why I wanted to know about how common it is and
> whether or not a person may know or not. It's a good thing for those
> researching LASIK to know NOT to opt for the procedure anyway (by not
> disclosing this condition to the surgeon perhaps if its not detected
> during the screening). Obviously it would be a contra-indication.
>
Intacs were originally developed to treat keratoconus, and not myopia.
In the Amoils series of 13 eyes with post-LASIK ectasia, the diagnosis
occurred from one week to 27 months after surgery.
DrG
| |
| Rebecca 2004-11-03, 11:10 am |
| Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<qutco01hs6ogrlgbccqtbt5sks0rstovt5@4ax.com>...
> Ectasia, although certainly undesired, is an effect that tends to
> stabilize. The patient may not get the desired "throw away your
> glasses" effect, but fortunately the net effect of ectasia is often
> that the patient remains myopic with no other vision health problems.
> For those with more extensive difficulties, ectasia is often
> manageable with rigid contacts, collagen crosslinking stabilization,
> Intacs, or in a worst case scenario; corneal transplants.
Glenn,
I have never heard, and hope that I never do hear, any corneal surgeon
describe the potential effects of ectasia in such a soothing manner.
Rebecca
| |
| Glenn - USAEyes.org 2004-11-03, 11:10 am |
| I don't just read his reports, I personally meet with Dr. Binder and
discuss such issues. If you actually read this report, you will see
that it is abundantly consistent with my points regarding ectasia.
[vbcol=seagreen]
| |
| Glenn - USAEyes.org 2004-11-03, 11:10 am |
| Well, I'm glad that the facts about ectasia seem soothing to you, but
why do you desire that surgeons not express the issues around ectasia
in "such a soothing manner"? Do you prefer WizKid's sky is falling
routine? Perhaps Keller's catastrophic language suits you better.
You can't really want a surgeon to freak out the patient when
explaining ectasia. That sounds downright cruel to me. Do you
perceive that there is some value in raising a patient's anxiety? I
don't.
Why, when factually confronting a patient with any problem, would you
NOT want the doctor to have a "soothing manner"?
Even if it does occur 3/50ths of one percent of the time, ectasia IS
an undesired malady that does tend to stabilize and can be
accommodated with glasses, contacts, collagen crosslinking, Intacs,
and/or remaining nearsighted. I don't know what is exactly soothing
about those facts. It's still an undesired malady. It's still not
what the patient (or doctor) want. It's still something that the
patient will have to deal with, one way or another.
I suppose that compared to WizKid and Keller's noise, the facts about
ectasia ARE soothing.
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.
| |
| Wizkid 2004-11-03, 7:12 pm |
| You are very good at double talk. A 250 micron bed is no guarantee,
and others agree that unknown factors contribute...as a result, one
cannot predict who will and who will not suffer from ectasia.
Secondly, we do not really know about lamellar surgery ala Barraquer
and its durability over time. How many of his patients were followed
longitudinally? Finally, if ectasia does occur, it is a disaster and
it is permanent. Your spin makes it sound tame, which it is not. WK
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<80vho09hjvs4sljlj8ca49k9rctdkct3ar@4ax.com>...[vbcol=seagreen]
> I don't just read his reports, I personally meet with Dr. Binder and
> discuss such issues. If you actually read this report, you will see
> that it is abundantly consistent with my points regarding ectasia.
>
| |
| Glenn - USAEyes.org 2004-11-03, 7:12 pm |
| >You are very good at double talk.
The only double talk is of the literal kind. I have had to repeat
myself many times on this issue.
>A 250 micron bed is no guarantee,
>and others agree that unknown factors contribute...
There are no guarantees in any surgery, but the 250 micron minimum has
been well established and is codified in FDA approvals. More is
always better, but as I have said many, many times, a healthy cornea
with at least 250 microns of untouched tissue will not develop
ectasia. There is a statistically suspect handful of outliers that
are exceptions to this rule, but one at a time these are being found
to be either thinner than the 250 microns or eyes with disease.
>as a result, one
>cannot predict who will and who will not suffer from ectasia.
How about if you actually answer one of my questions, rather than rant
on about issues you cannot substantiate: What to YOU believe to be
the safe minimum untouched cornea required in a healthy eye and how do
you substantiate that number?
>Secondly, we do not really know about lamellar surgery ala Barraquer
>and its durability over time. How many of his patients were followed
>longitudinally?
I hope you don't embarrass yourself in front of peers with statements
like that. It is laughable on its face. If you don't like
Barraquer's data, just look at the scores of studies conducted in the
last 50 years.
>Finally, if ectasia does occur, it is a disaster and
>it is permanent. Your spin makes it sound tame, which it is not. WK
First of all, ectasia is not necessarily permanent. Apparently you
are not up to date on the latest treatments.
"Disaster" is a relative term, but those 3/50th of one percent who do
develop ectasia have available contacts, glasses, Intacs, collagen
crosslinking, or simply being a bit nearsighted.
[vbcol=seagreen]
| |
| serebel 2004-11-03, 10:09 pm |
| RT <RTMD24@NOSPAMyahoo.com> wrote in message news:<RTMD24-A5DD59.07382303112004@newssvr13-ext.news.prodigy.com>...
> In article <6ddf3bb5.0411021758.2722b6a9@posting.google.com>,
> serebel@aol.com (serebel) wrote:
>
>
> well, then it may be more like my chances of being hit by a meteorite,
> which my son informs me is 4x more likely than lightning
>
> Seriously though, I don't think being aware of possibilities is
> practicing chicken little. I've always been concerned about the
> relative infancy of this procedure and whether or not there may be
> things to look out for in the long term. I had never heard about
> ecstasia before reading this group post-LASIK. If a potential LASIK
> patient is armed with this info pre-procedure all the better for
> her/him. That's why I wanted to know about how common it is and whether
> or not a person may know or not. It's a good thing for those
> researching LASIK to know NOT to opt for the procedure anyway (by not
> disclosing this condition to the surgeon perhaps if its not detected
> during the screening). Obviously it would be a contra-indication.
Being informed of the possibilities is one thing, but the way Wizzer
and Sandy presents them, it goes way past possibility.
Meteorites? Good thing I have a hard hat.
SErebel
| |
| Rebecca 2004-11-03, 10:09 pm |
| Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<hbvho0tslcbm53glbh47soqqngcs6bet1t@4ax.com>...
> Well, I'm glad that the facts about ectasia seem soothing to you, but
> why do you desire that surgeons not express the issues around ectasia
> in "such a soothing manner"? Do you prefer WizKid's sky is falling
> routine? Perhaps Keller's catastrophic language suits you better.
> You can't really want a surgeon to freak out the patient when
> explaining ectasia. That sounds downright cruel to me. Do you
> perceive that there is some value in raising a patient's anxiety? I
> don't.
>
> Why, when factually confronting a patient with any problem, would you
> NOT want the doctor to have a "soothing manner"?
Oh for bloody crying out loud!
The topic of these threads for how many days now has been, NOT the
bedside of manners confronting patients with problems, but the
discussion of the RISKS OF ECTASIA. That has been the topic your
posts, my posts, WK's posts. You must be desperate to avoid the point
if you have to twist it in a ridiculous direction like this.
| |
| Glenn - USAEyes.org 2004-11-03, 10:09 pm |
| >Oh for bloody crying out loud!
Indeed Rebecca. For crying out loud.
>I have never heard, and hope that I never do hear, any corneal
>surgeon describe the potential effects of ectasia in such a soothing manner.
Above is your statement regarding one of my posts where I discuss the
risks of ectasia and possible corrective responses. I did not bring
up the point of a "soothing manner"; you did. I am not desperate nor
am I twisting anything any direction. I am simply and frankly
responding to the statement you made. The statement quoted above.
To reiterate my point to which you have not directly responded, why
would anyone NOT want a corneal surgeon discuss the potential effects
of ectasia in a "soothing manner". It is the point you made. It is
the direction you took this thread. You have no calling to snap at me
because I take exception to your statement.
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.
| |
| Ragnar Suomi 2004-11-04, 2:10 am |
| Wizkid, you really are obsessed with ecstasia. Give it a rest. You
are going nuts about 250 microns not being enough. In RK, the
incisions are over 475 microns deep leaving only 10 to 25 microns of
cornea uncut. They have to cut that deep to get the bulging they
need.
You just keep posting the same garbage ad nauseum and thing people are
going to be scared. You are just making a fool of yourself.
On 3 Nov 2004 14:12:04 -0800, gospa68@aol.com (Wizkid) wrote:
[vbcol=seagreen]
>You are very good at double talk. A 250 micron bed is no guarantee,
>and others agree that unknown factors contribute...as a result, one
>cannot predict who will and who will not suffer from ectasia.
>Secondly, we do not really know about lamellar surgery ala Barraquer
>and its durability over time. How many of his patients were followed
>longitudinally? Finally, if ectasia does occur, it is a disaster and
>it is permanent. Your spin makes it sound tame, which it is not. WK
>
>Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<80vho09hjvs4sljlj8ca49k9rctdkct3ar@4ax.com>...
| |
| Rebecca 2004-11-04, 7:16 pm |
| Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<vm6jo0po63p225ge1ltnsn04djnhqhclp8@4ax.com>...
[vbcol=seagreen]
> Above is your statement regarding one of my posts where I discuss the
> risks of ectasia and possible corrective responses. I did not bring
> up the point of a "soothing manner"; you did. I am not desperate nor
> am I twisting anything any direction. I am simply and frankly
> responding to the statement you made. The statement quoted above.
>
> To reiterate my point to which you have not directly responded, why
> would anyone NOT want a corneal surgeon discuss the potential effects
> of ectasia in a "soothing manner". It is the point you made. It is
> the direction you took this thread. You have no calling to snap at me
> because I take exception to your statement.
Alright, fair enough.
I will now attempt to re-state my point, on the basis that all context
shall be disregarded rather than assumed to have been read, and I will
amplify and rephrase my original statement in language that will
hopefully be clearer.
In my personal experience and observation, corneal surgeons, when
speaking either (a) in a peer-to-peer environment, such as at a
medical conference or amongst themselves in a private setting, or (b)
in a consultation with a candidate for surgery, do not talk about
ectasia in such terms as to appear to dismiss it as something that is
merely undesireable but which also has many mitigating factors.
I believe that in general, corneal surgeons, when they discuss ectasia
amongst themselves or in pre-operative counseling, tell it like it is:
Ectasia is a complication which they want to avoid wherever and
however possible because - any mitigating factors notwithstanding - it
does have quite serious long-term implications for the cornea, the
preservation of the health and function of which is the essence of
their profession.
If the absence of any reference to the incidence of ectasia, or to
post-operative treatment of patients with ectasia, is insufficient to
prevent further confusion (or, sigh, the unpreventable, further
obfuscation), I don't have anything further to say.
On the other hand... 
I could talk plain English and say Glenn, you seem to have very
different views on ectasia than most doctors I know. Personally I vote
with the doctors.
| |
| Glenn - USAEyes.org 2004-11-04, 7:16 pm |
| Your original statement references communication between patients and
doctors, not between doctors. My response is relevant to what you
stated. If what you actually meant was communication between doctors,
then my response would be quite different.
Ectasia is a serious problem when it occurs and I don't know of any
doctors who think otherwise. Neither do I. I just don't think that
patients need to be unnecessarily worked into a frenzy when they are
confronted with a complication.
Conversations between doctors is a whole different matter than the
situation your statement appeared to present. An exchange of ideas
between peers who (should) already have an understanding of the
relevant issues is not the same as a doctor telling a patient they
have a serious complication. I was quite surprised when your original
statement indicated you thought a doctor confronting a patient with
news of a complication like ectasia should NOT use a "soothing" tone.
Sorry for the confusion, but I believe you can understand why your
previous statement would not have belied what you now have clarified
as your original intent.
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.
| |
| Wizkid 2004-11-04, 10:10 pm |
| I am not obsessed with ectasia. I AM OBSESSED WITH POOR INFORMED
CONSENT!! Patients are told very little, if anything, about ectasia.
While some steps can be taken to alleviate it, it's origins are not
known. If you can get to an ophthalmic meeting and gain the trust of
some LASIK surgeons, you will find that ectasia is the Pink Elephant
in the room. It is more widespread than what is being admitted.
Contrary to others that post here, there is concern since we do not
really understand fully the "why."
RK is another matter. You are correct that the RK incision goes to 90%
depth. And we learned, ten years after the fact (despite protestations
by those vested in RK), that 40% of RK'd corneas are unstable (with
regression) at ten years. Patients were not informed on this potential
problem ("it was rare") then as patients today are not being informed
on post-LASIK ectasia.
One of the problems with my posts, as I have learned, is that when
someone is ahead of the curve, they can be treated as fools. But the
day will come when the fool will be seen as a prophet.
WK
Ragnar Suomi <ragnarsuomi@yahoo.com> wrote in message news:<aijjo0118ak17bkushdgk32m4m5s3m8oi2@4ax.com>...[vbcol=seagreen]
> Wizkid, you really are obsessed with ecstasia. Give it a rest. You
> are going nuts about 250 microns not being enough. In RK, the
> incisions are over 475 microns deep leaving only 10 to 25 microns of
> cornea uncut. They have to cut that deep to get the bulging they
> need.
> You just keep posting the same garbage ad nauseum and thing people are
> going to be scared. You are just making a fool of yourself.
>
>
> On 3 Nov 2004 14:12:04 -0800, gospa68@aol.com (Wizkid) wrote:
>
| |
| Glenn - USAEyes.org 2004-11-04, 10:10 pm |
| >I am not obsessed with ectasia. I AM OBSESSED WITH POOR INFORMED
>CONSENT!! Patients are told very little, if anything, about ectasia.
WizKid, please enlighten us with exactly what in your opinion needs to
be informed to patients regarding a complication that reportedly
occurs in 3/50ths of one percent of LASIK patients. I agree that
known complications should be included in an informed consent in some
manner. I'm curious if you can present something more substantial
than ranting and raving.
After 50 years of lamellar surgery, WizKid has it in his head that
suddenly everyone is hiding something about ectasia. It's all there,
in five decades worth of studies and reports, in the results from
millions of patients, in open forums and public conversations.
Ectasia exists, is a problem when it occurs, and (thankfully) is
relatively rare.
Wizzer, if you think you are "ahead of the curve" because you are
crying the sky is falling about something based upon a 50-year old
procedure, those who treat you like a fool may not be so very far off
the mark. I cannot help but visualize the proverbial old man with a
beard wearing white robes and Birkenstocks walking around with a sign
that says "The (ectasia) End Is Near". You are only a prophet of
gloom and doom.
And you still have not responded to my two simple and direct
questions. Now I have posed a third. See if you can respond to it.
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.
| |
|
| In article <r9rlo0573o351mh42smgpopg5cfhim8ra2@4ax.com>,
Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote:
> WizKid, please enlighten us with exactly what in your opinion needs to
> be informed to patients regarding a complication that reportedly
> occurs in 3/50ths of one percent of LASIK patients. I agree that
> known complications should be included in an informed consent in some
> manner. I'm curious if you can present something more substantial
> than ranting and raving.
In this case I agree with WizKid. On my consent form, blindness was
listed as a possible complication, but I had never heard of ecstasia.
Is blindness a more common complication?
| |
| Glenn - USAEyes.org 2004-11-05, 11:09 am |
|
>In this case I agree with WizKid. On my consent form, blindness was
>listed as a possible complication, but I had never heard of ecstasia.
>Is blindness a more common complication?
I think we all agree with WizKid that known complications should be
included in an informed consent. I'm simply asking WizKid to supply
an example of the language that he believes would be appropriate.
"You may go blind" is not exactly detailed information.
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.
|
| |
|
|