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Safety
& Improved Vision |
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Q:
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Are
there any independent (unsponsored) clinical studies that
support IntraLase's claims? |
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Q:
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Has
IntraLase proven to effectively lowered complication rates? |
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Q:
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Is
traditional LASIK unsafe? |
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Q:
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Can
IntraLase improve the visual results of LASIK? |
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Q:
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Is
visual recovery faster with IntraLase? |
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Q:
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Is
it true that IntraLase makes it possible for people with
thin or flat corneas to have LASIK? |
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Q:
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Are
there any complications with IntraLase? |
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Q:
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Is
it true that that some IntraLase lasers were recalled? |
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Comparison:
IntraLase and the Microkeratome (Blade) |
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Q:
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Is
IntraLase safer than the microkeratome (blade)? |
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Q:
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Does
the IntraLase create a more precise and uniform flap than
the microkeratome (blade)? |
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Q:
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Does
the IntraLase create a smoother flap than the microkeratome
(blade)? |
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Q:
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Does
the IntraLase "rough cut" the flap and have to
be "peeled" back? |
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Q:
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How
common are microkeratome (blade) flap complications? |
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Q:
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Is
it true that a doctor only has one chance to cut a flap
when using a microkeratome (blade)? |
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General
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Q:
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Why
was the IntraLase laser developed? |
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Q:
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How
does IntraLase change the LASIK procedure? |
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Q:
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Have
many patients have had the IntraLase procedure? |
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Q:
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How
long does the IntraLase procedure take? |
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Q:
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Is
IntraLase more expensive? |
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Q:
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Are there any
independent (unsponsored) clinical studies
that support IntraLase's claims? |
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A:
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Absolutely. Such
results have been confirmed by multiple independent studies,
including a study by one of the world's most respected research
facilities - the Naval Medical Center in San Diego. Dr.
Steve Schallhorn, a navy captain and ophthalmologist, oversaw
the study, mandated and funded by the US Defense Department
for the purpose of identifying the best LASIK treatment
for Navy aircraft carrier pilots. Preliminary results from
the 199-patient study showed that IntraLase patients had
better contrast sensitivity and visual results "at
all postoperative periods", said Dr Schallhorn. "The
crispness and clarity of vision, especially at night, is
a very important outcome for us," he added. The results
are preliminary but if confirmed, as expected, "we
will likely use IntraLase to cut flaps for our aviators."
Dr. Schallhorn also said he saw no evidence of "delayed
acute photophobia," a debilitating problem that some
surgeons have reported between six and seven weeks after
IntraLase use.
And in a different study, patients who had a preference
preferred the vision in their IntraLase treated eye over
the mechanical microkeratome (blade) treated eye 3 to
1.
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Q:
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Has IntraLase
proven to effectively lowered complication rates? |
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A:
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Yes. Eye care providers
that have incorporated the IntraLase laser have, on average,
decreased their retreatment rates by 4.2% (or 4.2 eyes for
every 100 eyes treated).
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Q:
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Is traditional
LASIK unsafe? |
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A:
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No, but IntraLase
reduces the risk of complications reported with the microkeratome
(blade) and has given many patients more confidence in choosing
laser vision correction. In fact, with no blades or blade-related
complications to worry about, 78% of patients, when given
a choice, chose to have the flap procedure performed with
the IntraLase laser over a hand-held microkeratome (blade)
blade.
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Q:
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Can IntraLase
improve the visual results of LASIK? |
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A:
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Yes. Studies show
that more patients achieve 20/20 vision or better with IntraLase.
With IntraLase, the surgeon uses the precision of a computer-guided
laser to create the corneal flap. IntraLase delivers micron-level
accuracy 100 percent greater than that of a microkeratome
(blade), giving the surgeon more control during the procedure
and the ability to establish precise dimensions and thickness
of the corneal flap, factors which are critical to a successful
LASIK outcome.
IntraLase allows surgeons to tailor the corneal flap
for each individual patient, and each individual eye.
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Q:
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Is visual recovery
faster with IntraLase? |
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A:
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Yes. Clinical studies
show that recovery times are faster with the IntraLase than
they are with the microkeratome. This is true for both standard
LASIK and Custom LASIK patients.
IntraLase flaps facilitate faster healing, due to a superior
self-sealing flap. With a smoother surface, uniform thickness,
and beveled edges, the IntraLase flap fits snug like a
manhole cover, to better resist unwanted movement and/or
infection.
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Q:
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Is it true that
IntraLase makes it possible for people with thin or flat
corneas to have LASIK? |
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A:
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Yes. With IntraLase,
people with thin corneas who once were unsuitable for
LASIK may now be candidates. Most people have corneas
that are between 500 and 600 microns thick, and most microkeratome
(blade)s cut flaps ranging between 100 and 200 microns
thick. Because of its precision, the IntraLase appears
capable of more reliably and consistently producing corneal
flaps as thin as 100 microns. This means surgeons now
have more options to perform LASIK in people with thinner
and flatter corneas.
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Q:
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Are there any
complications with the IntraLase laser? |
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A:
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Independent (unsponsored)
studies indicate that there are significantly fewer LASIK
complications associated with IntraLase. Still, a few surgeons
have reported some cases of transient (or temporary) sensitivity
to light. Thie post-operative effect is easily resolved
with steroid treatment (eye drops) lasting only a few weeks.
Some surgeons may claim additional IntraLase-related complications,
including statements from sponsored (or paid) studies and
cursory data from 4-year old, first generation IntraLase
technology (no longer available). Since then, many of these
same surgeons have purchased an IntraLase system.
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Q:
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Is it true that
that some IntraLase lasers were recalled?
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A:
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Yes. In 2002 and
2003 IntraLase recalled a small number of its earlier generation
lasers in the US, Japan and Mexico (100 in total). The recalls
were made as a preventative measure and not the result of
reported patient injury. Some websites have tried to use
the recalls as "hype" to denounce the IntraLase.
Details on both IntraLase recalls can be found on the
FDA (Federal Drug Administration) website below:
http://www.fda.gov/bbs/topics/enforce/2003/ENF00810.html
http://www.fda.gov/bbs/topics/enforce/2002/ENF00767.html
Note: Product recalls are common in every industry
and not an effective indicator of product inferiority.
Such processes are meant as safeguards, put in place by
regulatory and manufacturing bodies to ensure the safety
of patients. This applies to all medical equipment, including
microkeratome (blade)s.
Thousands of mechanical microkeratome (blade)s and microkeratome
(blade) blades have been recalled, due to various technical
defects greatly impacting both use and patient safety
(including reports of patient injury). Listed reasons
for microkeratome (blade) recalls included:
- Kerotome Blade may fail to oscillate properly and cause
corneal abrasion
- Degradation of glue causes glass movement resulting
in misalignment that can cause deeper cuts than anticipated
(4 patient injuries reported)
- microkeratome (blade) Blade may cause irregular corneal
flap, which may delay patients' procedure
A partial listing of known microkeratome (blade) recalls
can be found at the following websites:
http://www.escrs.org/eurotimes/Jan2003/popular.asp
http://www.fda.gov/bbs/topics/enforce/2002/ENF00726.html
http://www.fda.gov/bbs/topics/enforce/2003/ENF00788.html
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Q:
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Is IntraLase
safer than the microkeratome (blade)? |
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A:
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Yes. Independent
studies show that IntraLase greatly improves the safety,
precision and visual results of LASIK, whether you choose
to have a standard or custom procedure.
Eye care providers that have incorporated the IntraLase
laser have, on average, decreased their re-treatment rates
by 4.2% (or 4.2 eyes for every 100 eyes treated).
The improved safety is a result of the superior precision
provided by the silent, computer-guided laser, which allows
the surgeon to accurately and uniformly control flap architecture
(including the size, shape and thickness of the flap,
from edge to edge).
Contrary to the claims of some competitors, comparative
studies using Scanning Electron Microscopes (SEM) (below)
prove that IntraLase is 3 times as precise as the leading
microkeratome (blade).
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Q:
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Does the IntraLase
create a more precise and uniform flap
than the microkeratome (blade)? |
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A:
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Yes. IntraLase
provides the highest degree of precision and uniformity.
IntraLase's micron-level precision creates significantly
more predictable and accurate flap dimensions, including,
most critically, reproducible flap thickness, within ±
10 microns, whereas variability with microkeratome (blade)s
has been reported up to ± 40 microns. This increased
precision preserves valuable corneal tissue and improves
the predictability of the LASIK treatment.
By cutting a smoother, more uniform flap the surgeon
can avoid aberrations (or visual defects) caused by cutting
into deeper layers of the cornea. microkeratome (blade)s
vary in depth, cutting across different layers of the
cornea, which can induce small, yet permanent visual defects
(or Higher Order Aberrations, HOA), resulting in less
than optimal outcomes.
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Q:
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Does the IntraLase
create a smoother flap than the microkeratome (blade)? I
have read on other websites that it is a rougher surface.
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A:
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Yes. The micron-level
accuracy of the IntraLase laser creates a much smoother
corneal surface than that of a traditional surgical blade.
A smoother corneal surface improves the accuracy and efficiency
of the LASIK procedure. References to a rougher surface
which other sources refer to are most likely the 1st or
2nd generation IntraLase laser.
Below: Using a Scanning Electron Microscope (SEM),
surgeons compared the surfaces of microkeratome (blade)
and IntraLase flaps. As shown below, the IntraLase flap
has a much smoother corneal surface than the microkeratome
(blade) (images provided by Dr. Richard Foulkes).
Click
to enlarge...
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Q:
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Does the IntraLase
"rough cut" the flap and have to be "peeled"
back? |
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A:
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No. Such statements
are based on first-generation, four year-old IntraLase technology
no longer available.
Newer 30kHz and 60kHz models cleanly and completely divide
the flap at a molecular level, resulting in a much smoother
corneal surface. Unlike the microkeratome (blade), there
is no heat or impact to surrounding tissue; as such the
risk of flap abrasion, tearing, folding and/or stretching
is eliminated. After the IntraLase procedure, the corneal
flap is easily & effortlessly lifted out of the way
like the page of a book. After the LASIK procedure, the
flap is gently laid back in place.
Detailed scans (above)
from a Scanning Electron Microscopes (SEM) prove that
the IntraLase produces a much smoother, cleanly divided
corneal flap. A smoother corneal surface improves the
accuracy of the LASIK procedure and allows for a more
rapid visual recovery.
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Q:
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How common are
microkeratome (blade) flap complications? |
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A:
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While LASIK complications
are relatively rare, they are or often associated with the
oscillating blade used with traditional microkeratome (blade)s.
Previous studies have reported incidence rates from 0.7%
to 11.8%, with larger patient populations showing an average
of 2.2% or less. Flap related complications may result
in such problems as infection, scarring and surface irregularities
that cause visual aberrations (or vision defects).
When complications do occur, they are usually resolved
through re-treatments. Otherwise, it is very rare for
a LASIK patient to incur permanent or significant vision
loss.
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Q:
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Is it true that
a doctor only has one chance to cut a microkeratome (blade)
flap? |
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A:
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A failed microkeratome
(blade) procedure (or partially cut flap) cannot be re-attempted
until the flap has completely healed. Subsequently, the
LASIK procedure is cancelled and the patient is sent home
for approximately 3 months (or more) before the surgeon
can re-attempt a LASIK procedure. During that time, the
partially cut flap may be susceptible to dislocation, ingrowth
and other various complications.
Unlike the microkeratome (blade), the IntraLase laser
can be stopped and started, at will, during the same procedure,
with no detrimental impact on the corneal flap or visual
result. The computer-controlled laser knows precisely
where to continue the cut, allowing the surgeon to continue
the procedure where he/she left off.
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Q:
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Why was the
IntraLase laser developed? |
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A:
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While LASIK complications
are rare, all surgery carries some degree of risk. It is
for this reason that the advanced IntraLase laser was developed
- to significantly reduce the majority of LASIK complications
that typically occur when using the traditional mechanical
microkeratome (blade) (or 'blade') to manually cut the corneal
flap.
IntraLase is the first blade-free laser technology used
to create the corneal flap. IntraLase virtually eliminates
the rare but severe sight threatening complications seen
with the microkeratome (blade), improving safety and precision
while providing predictably better visual results for the
patient. IntraLase is the most sophisticated and accurate
technology for corneal flap creation available today and
has given many patients greater confidence and assurance
in choosing laser vision correction.
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Q:
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How does IntraLase
change the LASIK procedure? |
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A:
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LASIK is actually
a two-step process. In the first step, the surgeon creates
a flap of corneal tissue and folds it back to prepare the
eye for the second step, where an excimer laser is used
on the inner cornea to correct vision. This two-step process
allows for rapid visual recovery with little or no patient
discomfort.
Traditionally, the corneal flap was created with a hand-held
oscillating razor blade, called the microkeratome (blade).
While this method has worked well over the years, the performance
of these devices can be unpredictable and is frequently
the source of a majority of LASIK complications.
With IntraLase, the surgeon uses the precision of a computer-guided
laser to create the corneal flap. IntraLase delivers micron-level
accuracy 100 percent greater than that of a microkeratome
(blade), giving the surgeon more control during the procedure
and the ability to establish precise dimensions and thickness
of the corneal flap, factors which are critical to a successful
LASIK outcome.
This level of precision is unparalleled by any other technology
in vision correction surgery. IntraLase allows surgeons
to tailor the corneal flap for each individual patient,
and each individual eye.
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Q:
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Have many patients
have had the IntraLase procedure?
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A:
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Yes. Since
2001, the IntraLase Method has been used in nearly a million
LASIK procedures around the world. Approximately one out
of every five LASIK procedures now starts with IntraLase.
And, in a recent study, patients showed a preference for
the vision in their IntraLase treated eye over the mechanical
microkeratome (blade) treated eye 3 to 1.
At Canadian eye centers with IntraLase, 80% to 100% of
patients are now choosing IntraLase. Doctors believe that
many patients have long-awaited the arrival of this safer,
bladeless technology.
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Q:
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How long does
the IntraLase procedure take?
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A:
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Creation of
an IntraLase flap takes, on average, only 15-30 seconds
per eye and a total of 10 minutes for the entire LASIK
procedure, which is comparable to—and sometimes faster
than—procedures using a microkeratome. The procedure is
quick, silent and much gentler on the eye than the oscillating
blade of the noisy, hand-held mechanical microkeratome
(blade). IntraLase patients feel much more comfortable
and reassured in their choice to have LASIK.
Note: Some competing centers may falsely
claim that the IntraLase procedure takes "minutes"
to perform, when in fact it only takes seconds. Such comments
usually refer to the first generation system.
The cleanly resected flap is then easily & effortlessly
lifted out of the way like the page of a book. There is
no tearing or stretching of the flap during this process,
due to the stronger and more stable structure of the IntraLase
flap. After the LASIK procedure, the flap is gently laid
back in place.
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Q:
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Is IntraLase
more expensive?
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A:
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Yes. Most patients
agree that the added level of safety, assurance and predictably
better vision offered by IntraLase is worth the incremental
cost. IntraLase surgeons are leaders in the field of ophthalmology
who continually evaluate advances in technology. They've
determined that the IntraLase is the most sophisticated,
advanced and accurate system available today for flap
creation and have invested in the technology to sustain
their leadership in patient care. For the clinic the IntraLase
is approximately 10 times the cost of a traditional microkeratome
(blade). Those surgeon's who invested in this technology
have done so because of their belief that this will offer
the highest level of safety and accuracy to their patients.
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REFERENCES:
* Tanzer DJ, Schallhorn SC, Brown MC, et al. Data on file,
IntraLase Corp. 2005.
** Will B, Kurtz RM. IntraLase is best. In: Probst LE, ed.
LASIK: Advances, Controversies, and Custom. Thorofare, NJ:
SLACK; 2004:397-402.
*** Durrie DS. How IntraLase raised the bar in refractive
surgery. Cataract Refract Surg Today. July 2003 (suppl):1-2.
**** Mahdavi S. IntraLase: coming of age. Cataract Refract
Surg Today. October 2005:117-120.
***** Davis EA. The time is now to switch to all-laser LASIK.
Ophthalmol Manage. March 2006:69-70.
****** Data on file, IntraLase Corp. |
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