To you, the discerning patient, laser
eye surgery is a very serious matter. To accurately
answer your queries, all claims below have been
substantiated with scientific proof from credible
sources. For further information, please consult
a qualified IntraLase surgeon or professional.
Safety & Improved Vision
|
| Q: |
Are
there any independent (unsponsored) clinical studies
that support IntraLase's claims? |
| Q: |
Has
IntraLase proven to effectively lowered complication
rates? |
| Q: |
Is
traditional LASIK unsafe? |
| Q: |
Can
IntraLase improve the visual results of LASIK? |
| Q: |
Is
visual recovery faster with IntraLase? |
| Q: |
Is
it true that IntraLase makes it possible for people
with thin or flat corneas to have LASIK? |
| Q: |
Are
there any complications with IntraLase? |
| Q: |
Is
it true that that some IntraLase lasers were recalled? |
Comparison: IntraLase and the Microkeratome (Blade)
|
| Q: |
Is
IntraLase safer than the microkeratome (blade)? |
| Q: |
Does
the IntraLase create a more precise and uniform
flap than the microkeratome (blade)? |
| Q: |
Does
the IntraLase create a smoother flap than the microkeratome
(blade)? |
| Q: |
Does
the IntraLase "rough cut" the flap and
have to be "peeled" back? |
| Q: |
How
common are microkeratome (blade) flap complications? |
| Q: |
Is
it true that a doctor only has one chance to cut
a flap when using a microkeratome (blade)? |
General
|
| Q: |
Why
was the IntraLase laser developed? |
| Q: |
How
does IntraLase change the LASIK procedure? |
| Q: |
Have
many patients have had the IntraLase procedure? |
| Q: |
How
long does the IntraLase procedure take? |
| Q: |
Is
IntraLase more expensive? |
|
| Q: |
Are there any independent (unsponsored)
clinical studies
that support IntraLase's claims? |
| A: |
Absolutely. Such results have been
confirmed by multiple independent studies, including
a large 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.
During the Naval study, a total number of 736 eyes were treated. Results showed that IntraLase created a superior flap and that patients treated with the IntraLase laser had better
low-light contrast sensitivity and visual results.1
"The crispness and clarity of vision, especially
at night, is a very important outcome for us,"
said Dr. Schallhorn.
Only with the IntraLase Method, does the US Navy now allow their aviators to have LASIK laser vision correction.
Click here to view press release on groundbreaking Naval study...
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| Q: |
Has IntraLase proven to effectively
lowered complication rates? |
| A: |
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).2
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| Q: |
Is traditional
LASIK unsafe? |
| A: |
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.3
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| Q: |
Can
IntraLase improve the visual results of LASIK? |
| A: |
Yes. Studies show that more patients
achieve 20/20 vision or better with IntraLase.1,4
With IntraLase, the surgeon uses the precision of
a computer-guided laser to create the corneal flap.
IntraLase delivers micron-level accuracy much
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: |
Is visual recovery faster with IntraLase? |
| A: |
Yes. Clinical studies show that recovery times are faster with the IntraLase than they are with the microkeratome.1 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, that fits more snugly than the microkeratome flap, to better resist unwanted movement and/or infection.
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| Q: |
Is it true that IntraLase makes it possible for people with thin or flat corneas to have LASIK? |
| A: |
Yes. With IntraLase, people with thin corneas who once were unsuitable for LASIK may now be candidates.5 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: |
Are there any complications with the IntraLase laser? |
| A: |
Independent (unsponsored) studies indicate that there are significantly fewer LASIK complications associated with IntraLase.2 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: |
Is it true that that some IntraLase lasers were recalled?
|
| A: |
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 (blades).
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: |
Is IntraLase
safer than the microkeratome (blade)? |
| A: |
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.1,5,6
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).2
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: |
Does the IntraLase create a more precise and uniform flap
than the microkeratome (blade)? |
| A: |
Yes. IntraLase provides the highest degree of precision and uniformity.6 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: |
Does the IntraLase create a smoother flap than the microkeratome (blade)? I have read on other websites that it is a rougher surface.
|
| A: |
Yes. The micron-level accuracy of the IntraLase laser creates a much smoother corneal surface than that of a traditional surgical blade.7 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).
Click
to enlarge image...
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| Q: |
Does the IntraLase "rough cut" the flap and have to be "peeled" back? |
| A: |
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: |
How common are microkeratome (blade) flap complications? |
| A: |
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: |
Is it true that a doctor only has one chance to cut a microkeratome (blade) flap? |
| A: |
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: |
Why was the IntraLase laser developed? |
| A: |
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: |
How does IntraLase change the LASIK procedure? |
| A: |
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 much 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: |
Have many patients have had the IntraLase procedure? |
| A: |
Yes. Since 2001, over one million blade-free IntraLase procedures have been performed 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 1.3
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: |
How long does the IntraLase procedure take?
|
| A: |
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: |
Is IntraLase more expensive? |
| A: |
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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1. Tanzer DJ, Schallhorn
SC, Brown MC, et al. Data on file, IntraLase Corp. 2006.
2. Mahdavi S. IntraLase: coming of age. Cataract Refract
Surg Today. October 2005:117-120.
3. Shareef Mahdavi: How IntraLase technology is impacting
the refractive practice. SM2 Consulting, Pleasanton,
CA. April 2004. Data on file, IntraLase Corp.
4. Durrie DS, Kezirian GM. Femtosecond laser versus
mechanical keratome flaps in wavefront-guided in situ
keratomileusis. J Cataract Refract Surg. 2005:31;120-126.
5. Will B, Kurtz RM. IntraLase is best. In: Probst LE,
ed. LASIK: Advances, Controversies, and Custom. Thorofare,
NJ: SLACK; 2004:397-402.
6. Durrie DS. How IntraLase raised the bar in refractive surgery. Cataract Refract Surg Today. July 2003 (suppl):1-2.
7. Data on file, IntraLase Corp.
