|
|
|
 |
 |
|
|
Bausch & Lomb Study Demonstrates IntraLase(R) FS Laser Produces Superior Flap
IntraLase Laser Flap Achieved a 30% Reduction in
Standard Deviation Versus the B&L XP Bladed
Microkeratome
IRVINE, Calif., Oct. 13 /PRNewswire-FirstCall/
-- IntraLase Corp. (Nasdaq: ILSE) today commented
on recent claims made in a head-to-head study
concerning the comparative outcomes of Bausch
& Lomb's bladed microkeratome device versus
IntraLase's Femtosecond (FS) laser instrument.
A Bausch & Lomb sponsored study performed
by Dr. Hung Ming Lee (Tan Tock Seng Hospital,
Singapore) demonstrates superior precision for
the IntraLase FS laser and equivalent short term
visual results, even though the newest IntraLase
model was not used. Moreover, the setting selected
for the IntraLase flap thickness was unusually
high. In fact after this study Dr. Lee now uses
the IntraLase FS laser in the majority of his
LASIK cases.
The study, which is being presented at a Bausch
& Lomb sponsored symposium, is not part of
the peer-reviewed annual meeting of the American
Academy of Ophthalmology being held this week
in Chicago. Data released by B&L compared
standard refractive results and contrast sensitivity
at one day, one week, and one month post-operatively.
Patients participating in the study had flaps
created in one eye by the Zyoptix XP and in the
fellow eye by the IntraLase FS laser operating
at 15 kiloHertz (the older model). Intraoperative
measurements revealed the achieved flap thickness
averaged 118 microns in the Zyoptix eye, but was
30% thicker (156 microns) in the IntraLase eye.
Unlike a mechanical microkeratome, the IntraLase
FS is computer controlled and can be set to achieve
a wide range of flap thickness. In several peer
reviewed clinical studies (and in general clinical
practice) a much thinner flap thickness is programmed
into the laser and achieved, usually between 100
and 120 microns. Thicker flaps have been reported
to result in slower visual recoveries, more significant
biomechanical effects and optical aberrations.
Two separate prospective, contralateral eye studies
done in the United States at the US Navy Medical
Center and at Stanford University comparing the
IntraLase FS laser and mechanical microkeratomes
are being presented at the AAO Refractive Subspecialty
Meeting, and the main AAO Annual Meeting, both
peer reviewed meetings. In these two studies,
Dr. Edward Manche (Stanford University) and Drs.
Steven Schallhorn and David Tanzer (U.S. Naval
Medical Center) achieved flaps of 110 and 100
microns, respectively. In both studies, statistically
significant improvements in contrast acuity and
uncorrected vision were seen with the IntraLase
FS.
More Good News for IntraLase
Despite the use of a flap thickness setting that
was 50% greater than a typical IntraLase setting,
and over 30% thicker than the thickness selected
for the Zyoptix XP, the IntraLase flap achieved
a 30% reduction in standard deviation versus the
mechanical device. In the IntraLase eyes, a standard
deviation of 9.5% was achieved, while for the
Zyoptix XP the standard deviation was 12.3% of
the average flap thickness. If equivalent flap
thickness had been used in the study, a standard
deviation of 11 microns would have been expected
with the IntraLase, versus 15 microns with the
Zyoptix XP. This 11 micron extrapolation is consistent
with several previous peer-reviewed publications
of the IntraLase FS. (Data on file)
IntraLase FS Laser Creates Planar Flap
Creation of a planar flap has been suggested
as one of the primary reasons for superior visual
results with the IntraLase FS. While a mechanical
microkeratome produces an irregular flap that
is thinner centrally and thicker peripherally
(meniscus shaped), the IntraLase FS creates a
uniform thickness flap. Therefore, even a uniformly
thicker IntraLase flap may better preserve the
integrity of the peripheral cornea and introduce
fewer biomechanical effects and optical aberrations
than a centrally thinner mechanical one. The equivalent
visual results between IntraLase planar 156 micron
flaps and Zyoptix XP 118 meniscus-shaped flaps
are consistent with this hypothesis.
Core Computer Technology Continues to Evolve
The study reports a two fold increase in suction
time. With the current model IntraLase FS30 the
suction times would be roughly equivalent (56
sec for FS30 vs. 44 sec for XP). Moreover the
highest volume LASIK surgeons in the world use
IntraLase as their standard of care dispelling
any myths of prolonged surgery time. And the core
computer technology used in the IntraLase platform
continues to increase in speed.
The Bottom Line
"After using both the new Bausch & Lomb
XP and the IntraLase FS30, I am convinced the
30 kHz IntraLase provides both better control
of flap thickness and flap architecture and drives
better visual outcomes. Our patients definitely
prefer the laser over the blade. This is why we
use IntraLase on essentially all of our patients,"
states Jon Dishler MD of the Laser Institute of
the Rockies.
IntraLase congratulates Dr. Lee on his clinical
study with Bausch & Lomb. We are especially
pleased to note that, after his comparison study,
he uses the IntraLase FS laser on the vast majority
of his LASIK cases.
About IntraLase:
IntraLase designs, develops and manufactures
an ultra-fast laser, related software and disposable
devices used to create a corneal flap, the first
step in LASIK surgery for the correction of vision.
The company's products improve the safety, precision
and visual results of LASIK procedures by providing
a computer-controlled laser solution in place
of the hand-held mechanical, metal-bladed microkeratome
traditionally used to create corneal flaps. IntraLase
lasers are also used in surgical approaches to
the treatment of diseased corneas. The company's
lasers and disposable per procedure patient interfaces
are presently marketed throughout the United States
and 21 other countries. IntraLase is headquartered
and manufactures its products in Irvine, Calif.
For additional information, visit the company's
web site: http://www.intralase.com.
Forward Looking Statements:
Statements contained in this press release that
are not historical information are forward-looking
statements as defined within the Private Securities
Litigation Reform Act of 1995. Forward-looking
statements can be identified by the use of words
such as "believe," "expect,"
"anticipate," "intend," "plan,"
"estimate," "project," or
words of similar meaning, or future or conditional
verbs such as "will," "would,"
"should," "could," or "may."
Such forward-looking statements are subject to
risks and uncertainties that could cause actual
results to differ materially from those projected
or implied. Those risks and uncertainties include,
but are not limited to: the degree of continued
acceptance of LASIK surgery; potential complications
revealed by long-term follow up; the extent of
adoption of our product offering by LASIK surgeons;
general economic conditions; changes in federal
tax laws governing the ability of potential LASIK
patients to use pre-tax dollars to pay for LASIK
surgery; the scope of government regulation applicable
to our products; patients' willingness to pay
for LASIK surgery; our ability to compete against
our competitors; the effectiveness of our measures
to ensure full payment of procedure fees; the
occurrence and outcome of product liability suits
against us; our ability to adequately protect
our intellectual property; whether we become subject
to claims of infringement or misappropriation
of the intellectual property rights of others;
the continued availability of supplies from single-source
suppliers and manufacturers of our key laser components;
the ability of our managers, operations, and facilities
to manage our growth; the success of our expansion
into markets outside the United States; whether
we lose any of our key executives or fail to attract
qualified personnel; or if our new products or
applications fail to become commercially viable.
Certain of these risks and uncertainties, in
addition to other risks, are more fully described
in the company's quarterly report on form 10-Q
for the period ending June 30, 2005, as filed
with the Securities and Exchange Commission on
August 10, 2005.
These forward-looking statements are made only
as of the date of this press release, and the
company assumes no obligation to update or revise
the forward-looking statements, whether as a result
of new information, future events, or otherwise.
SOURCE IntraLase Corp.
10/13/2005
CONTACT: Shelley B. Thunen, Executive Vice President
and Chief Financial Officer of IntraLase Corp.,
+1-949-859-5230 x196, sthunen@intralase.com ,
or Kathy Waller, Executive Vice President of Financial
Relations Board, +1-312-640-6696, kwaller@financialrelationsboard.com
Web site: http://www.intralase.com
(ILSE)
10/13/2005 17:20 EDT http://www.prnewswire.com
|
|
|
|
