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Home > Archive > Lasik Eyes Surgery > April 2005 > LASIK - The emperor has no clothes - Part II
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LASIK - The emperor has no clothes - Part II
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| gospa68@aol.com 2005-04-19, 10:51 am |
| All will enjoy this...particularly the part about the "previously
overlooked" descriptor. For those who have been in the loop, I believe
that you will agree that a more accurate statement would be "A
previously ignored and swept under the rug aspect of the LASIK
procedure...." All of us have known about the uneveness of the LASIK
contour for years. This is nothing new. But now that IntraLase is
trying to gain share, the news is being broadcast publicly. And in
three years when the next new iteration of LASIK comes along, we will
be reading about the problems of the IntraLase created flap...like
extreme light sensitivity. This, too, is being ignored and swept under
the rug. WK
New Science of LASIK Reveals IntraLase Laser Key to Better Than 20/20
Vision; ASCRS Data Show LASIK's First Step - Creation of the Corneal
Flap - Underestimated for Its Affect on Visual Outcomes
American Society of Cataract and Refractive Surgery Meeting
WASHINGTON--(BUSINESS WIRE)--April 15, 2005--
Corneal Architecture "Below-the-Flap" Found Integral to Better Vision
A previously overlooked (??????) aspect of the LASIK procedure, the
creation of the corneal flap, plays a significant role in the visual
outcome of the procedure, according to new clinical research being
presented this week at the annual meeting of the American Society for
Cataract and Refractive Surgery (ASCRS) in Washington, D.C.
Data from multiple clinical studies show statistically and clinically
significant differences in the vision patients achieve when the
IntraLase(R) FS laser (IntraLase Corp. (NASDAQ:ILSE)) is used for
corneal flap creation in LASIK's first step. It appears the IntraLase
laser, originally designed to create a safer flap, also provides for
vision better than 20/20, particularly among Custom LASIK patients.
"Until now, the role of the corneal flap has been underestimated," said
Roger F. Steinert, M.D., 2005 ASCRS President, Professor of
Ophthalmology, Professor of Biomedical Engineering, Director of Cornea,
Refractive and Cataract Surgery, and Vice Chair of Clinical
Ophthalmology at university of California, Irvine. "When we began using
the IntraLase laser to make corneal flaps, more patients achieved
vision better than 20/20, to 20/15 and even 20/12.5. We found
IntraLase-initiated LASIK does more than create a safer, more precise
flap. These outcomes relate directly to what the IntraLase laser does
below the flap: creating an optimal corneal architecture for the
procedure's second step, treatment by the excimer laser. If the corneal
surface is left with microscopic high and low spots, or irregular
hydration, the precision of the excimer tissue ablation can be
compromised, and with it the visual outcome."
Highlights of the new findings, including those being presented at
ASCRS, include:
-- A greater number of standard and Custom LASIK patients achieve
visual results better than 20/20 to 20/15 and 20/12.5 with
IntraLase-initiated LASIK. (Durrie, Faktorovich, Manche,
Tanzer/Schallhorn)
-- Prospective, randomized evaluation of wavefront aberrations shows
the IntraLase laser induces fewer higher- and lower-order aberrations
(associated with night glare and halos), allowing for a corneal surface
consistent with wavefront recordings taken pre-operatively. (Lim, Tran)
-- The planar architecture of the IntraLase flap and corneal bed
significantly reduces the incidence of post-operative induced
astigmatism - a complication that occurs with some frequency with the
microkeratome. (Kezirian, Stonecipher)
-- Patients who stated a preference in prospective, randomized clinical
trials chose the post-operative vision of their IntraLase-treated eye
up to 3-to-1 over their blade-treated eye. (Durrie, Manche)
For a complete list of ASCRS presentations visit: www.IntraLaseFS30.com
(for editorial use only). Consumer inquiries can be directed to
www.intralase.com.
Dr. Steinert, who also co-authored the ASCRS Eye Surgery Education
Council LASIK Guidelines, added: "As surgeons, we are driven to
increase our scientific understanding to ensure the best possible
visual outcomes are realized by our LASIK patients. The IntraLase laser
is the latest example of the new science of LASIK."
How the IntraLase Laser Works
Pulsing at a speed of one-quadrillionth of a second, the ultra-fast
IntraLase FS30 femtosecond (fem-to-second) laser uses an infrared beam
of light to prepare the intracorneal bed and create the flap, using an
"inside-out" process to complete the first step of LASIK.
-- The beam of laser light is focused to a precise point within the
cornea where a string of microscopic bubbles is formed.
-- Thousands of these tiny bubbles are precisely positioned to define
the architecture of the intracorneal surface, as well as the distinct
beveled edge of the resulting flap.
-- Bubbles are then stacked along the edge up to the corneal surface to
complete step one.
-- The IntraLase process from start to finish takes under 30 seconds,
on average.
-- The physician then lifts the flap to expose the prepared corneal bed
for treatment by the excimer laser (the second step of LASIK).
-- The LASIK procedure is completed when the flap is securely
repositioned thanks to its beveled edge.
The creation of a corneal flap prior to treatment by the excimer laser
was added to laser vision correction in the mid 1990s to provide
patient comfort and immediate visual results (the two factors credited
with the growth and popularity of LASIK). When laser vision correction
was performed without the corneal flap - as in PRK (photorefractive
keratotomy) - patients experienced considerable discomfort, as well as
a delay in visual acuity. So, in LASIK, the surgeon first creates a
micro-thin corneal flap, which is then lifted to expose the inner
cornea for the second step, vision treatment by an excimer laser.
Historically, the first step of LASIK was performed using a hand-held
device with an oscillating metal razor blade, called a microkeratome.
While LASIK has proven to be a successful and relatively safe
procedure, it is the microkeratome that caused the majority of LASIK
complications.
With the IntraLase laser, the surgeon can precisely control the
critical first step of LASIK. Physician-programmed laser specifications
include flap diameter, depth, hinge location and width, and side-cut
architecture - factors which can be varied to meet the individual
patient's needs. The IntraLase laser also creates a distinctive beveled
edge flap, which allows for precise repositioning, alignment and
seating after LASIK is completed.
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| Glenn - USAEyes.org 2005-04-19, 10:51 am |
| The LASIK flap was not "overlooked", as evidenced by Intralase
spending millions to develop a safer and more accurate way to create
flaps, and two surface ablation techniques (LASEK and Epi-LASIK) being
developed within the past few years.
Limitations of the LASIK flap are known, studied, well documented, and
are constantly being overcome by innovative development of new
technologies. The LASIK flap actually goes back to the 1950's when
Barraquer developed lamellar surgical techniques along with the advent
of the microkeratome.
Of course, if the patient is an appropriate candidate, a surface
ablation technique like PRK and its cousins LASEK and Epi-LASIK
eliminate the LASIK flap (and all possibility of LASIK flap
complications) completely.
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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| gospa68@aol.com 2005-04-19, 10:51 am |
| Yadda, yadda, yadda...you do not get it. It is not what the industry is
doing to improve the procedures and what we talk about in the hallways,
IT IS ALL ABOUT WHAT WE TELL THE PATIENTS. IT IS THEIR VISION. WE OWE
THEM A TRUE RISK ASSESSMENT WHEN THEY HAVE THE SURGERY NOT AFTER THEY
HAVE THE SURGERY, AND NEWER THINGS THAT WE WANT TO PROMOTE ARE COMING
ALONG.
THIS IS ALL ABOUT HOW THE PATIENT IS BEING INFORMED.
WK
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| Glenn - USAEyes.org 2005-04-19, 10:51 am |
| Yes, WizKid, it is all about how the patient is informed, and that
information starts right here. When you go on and on and on about a
complication that occurs in 35/100ths of one percent of LASIK patients
and has over four decades of data to back up that rate, people start
thinking that all the warnings are just zealot hyperbole...including
those warnings that are important. You can cry wolf only so long, and
in my opinion you have long ago crossed that threshold.
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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| gospa68@aol.com 2005-04-19, 10:51 am |
| I will stand by what I have said all along. The incidence of ectasia is
higher than what the studies are showing. The reason for the
underreporting has to do with how the exams are done, how the results
are being interpreted, and, finally, how it is all reported. Be patient
as time will bear this out. There are significant interests in this
field not to alarm patients, insurers, and litigators, while keeping
the revenue stream healthy...WK
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| serebel 2005-04-19, 10:51 am |
| Wizzer just likes to make up his own stats to suit his little fanatical
agenda.
SErebel
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| Ragnar 2005-04-19, 10:51 am |
| frankly, contracts and consent forms are pretty irrelevant. People
almost never understand them and would sign anything shoved in front
of them. For instance, at LVI, their consent form included a line
that said in the event of your death, you won't hold them liable!
That is incredible.
LASIK is the safest, most widely done procedure of all. Any medical
procedure needs to be safe and effective regardless of any silly form.
the fact that someone signed or didn't sign a form doesn't change an
outcome
On Sun, 17 Apr 2005 21:58:18 GMT, Glenn - USAEyes.org
<glenn.hageleSTOPSPAM@USAEyes.org> wrote:
>Yes, WizKid, it is all about how the patient is informed, and that
>information starts right here. When you go on and on and on about a
>complication that occurs in 35/100ths of one percent of LASIK patients
>and has over four decades of data to back up that rate, people start
>thinking that all the warnings are just zealot hyperbole...including
>those warnings that are important. You can cry wolf only so long, and
>in my opinion you have long ago crossed that threshold.
>
>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 2005-04-19, 10:51 am |
| Okay WizKid, let's say that you are right and all 30,000+
ophthalmologist throughout the world are misinterpreting data, doing
exams wrong, or otherwise covering up the true rate of ectasia. Let's
say that the real rate is twice, no, five times, no, TEN times the
rate reported. That would mean that the rate of ectasia under your
bizarre belief system is all of 3/10ths of one percent. That is, of
course, only if all the ophthalmologists in the world have been
conspiring against all patients in the world for the last four
decades.
Not very likely, is it.
No, it seems much more likely that you are simply wrong. In fact, not
only is it more likely, that is the reality.
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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