intralase - Austin Eye

Transcription

intralase - Austin Eye
INTERNAL MESSAGING
Uniquely Safe
Clinical Support:
Six different studies verify the improved safety of flap creation with the INTRALASE® FS laser when
compared to traditional microkeratomes. Clinical studies validate the elimination of certain risks
that may accompany laser vision correction using the traditional surgical blade. Specifically, fewer
case interruptions, fewer complications and the ability to safely create thin flaps and preserve corneal
tissue were all reported. These benefits combine to significantly improve the safety profile of the
LASIK procedure.
Supporting Statements:
1
Traditionally the first step of the LASIK procedure was performed with a hand held mechanical
device. While the results using this method have been very good, a new computer controlled laser is
now available that eliminates many of the possible complications that were occasionally seen with
the mechanical device. This INTRALASE FS laser enables us to provide remarkable predictability
and precision. It is this precision that makes laser vision correction enriched with IntraLase one of
the safest forms of surgical vision correction available today.
2
The advanced IntraLase technology has given many patients more confidence when considering
laser vision correction. Our surgeons recommend the INTRALASE FS laser for all of our patients
because it provides greater precision and may significantly reduce the possibility of risk.
3
IntraLase helps us minimize risk and optimize results, giving you better vision.
4
IntraLase technology takes a very good procedure to the next level, making it uniquely safe and
predictably better for our patients.
5
Many IntraLase surgeons report that the need to do a touch-up procedure, commonly known as an
“enhancement”, may be significantly reduced.
6
We have performed thousands of successful procedures at our center with the traditional LASIK
approach, and we have thousands of patients who are enjoying 20/20 vision. Much of our success is
due to the skill of our surgeon(s), and continual investment in advanced technology. That’s why the
IntraLase technology was chosen for our center. We want to continually provide the highest level of
patient care, and the laser’s incredible precision allows us to better control the quality of the entire
procedure.
7
Until now, the technology to totally customize vision correction surgery for every individual need
was simply not available. The most exciting part is that while offering the opportunity to obtain the
best results, we are also offering unprecedented safety and precision.
INTERNAL MESSAGING
Uniquely Safe
Sources
“Microkeratome Use in Conventional LASIK and the Use of the IntraLase® FS Laser to Create Corneal Flaps: The All Laser Procedure.”
Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes. Differences such as predictability and
measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Presented: 2002 American Academy of
Ophthalmology (IntraLase booth). Accepted: Journal of Cataract and Refractive Surgery, August 2003.
“The Femtosecond Laser and The Flap.” Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes.
Differences such as predictability and measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Published:
Review of Refractive Surgery, February 2003.
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria® and Hansatome® microkeratomes for flap
predictability, treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“Outcomes for LASIK Performed with a Femtosecond Laser Keratome.” Authors: J. Christenbury, MD, D. Kaswinkel, MD, J. Gallo, MD. Abstract: This
retrospective study reports the 1 month postoperative clinical outcomes of 300 eyes of 156 patients who underwent laser vision correction surgery with
the IntraLase FS laser keratome. Standard outcome measurements of visual acuity, manifest refraction and intraoperative and postoperative
complications are presented and are consistent with published data for traditional LASIK. Some possible safety advantages are presented including a
reduction in dry eye complaints and data supporting the same day completion of treatment interruptions with favorable visual outcomes. Presented: 2002
American Academy of Ophthalmology. 2003 American Society of Cataract and Refractive Surgery
“Thickness Measurements of Corneal Flaps Created with the IntraLase® FS Laser.” Authors: A. Chayet, MD, S. Litwak, MD. Abstract: This study
evaluated the thickness accuracy and predictability of corneal flaps created with the IntraLase FS laser by using subtraction pachymetry on 30 eyes of 17
patients. The mean thickness was measured at 132 ± 15 µm indicating the IntraLase FS laser creates highly accurate flaps of intended thickness which
significantly improves the safety profile of the overall procedure. Submitted: Archives of Ophthalmology, December 2002.
“Laser Creates Thin Flaps Safely.” Author: M. Gordon, MD. Abstract: This study evaluated the thickness accuracy of thin corneal flaps created with the
IntraLase® FS laser by using subtraction pachymetry on 69 eyes. The intended flap thickness was 100 µm and the mean thickness was measured at
103 ± 10.5 µm. Additionally, Dr. Gordon discusses the ease of handling these thin flaps as compared to those created by a mechanical keratome.
Published: EyeWorld, November 2002.
INTERNAL MESSAGING
Uniquely Precise
Clinical Support:
Eight different studies evaluated the precision of IntraLase technology in flap creation, comparing it
to standards using the mechanical microkeratome. These studies unanimously determined that the
laser-based approach generated significantly more predictable flap dimensions, most importantly flap
thickness. This increased predictability in flap creation enriches the accuracy of the overall treatment
as well as the ability to precisely create thin flaps and preserve corneal tissue.
Supporting Statements:
1
The precision our surgeons have been able to consistently attain while performing the first step of
the procedure with this laser directly affects the quality of the entire procedure.
2
Our surgeons believe this greater level of precision and accuracy provided by the IntraLase
technology is important for all of our patients. It allows us to continually provide a higher level of
care in our facility.
3
IntraLase technology gives you an important new reason to consider laser vision correction. By
eliminating the microkeratome (or surgical blade), our doctors believe that laser vision correction
is safer, better, and more precise.
4
Our doctors continually evaluate all advances in technology and have found that the computer
guided laser for creation of the first step of LASIK is the most sophisticated and accurate system
available today. IntraLase technology provides greater precision, safety and predictability.
INTERNAL MESSAGING
Uniquely Precise
Sources
“Microkeratome Use in Conventional LASIK and the Use of the IntraLase® FS Laser to Create Corneal Flaps: The All Laser Procedure.”
Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes. Differences such as predictability and
measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Presented: 2002 American Academy of
Ophthalmology (IntraLase booth). Accepted: Journal of Cataract and Refractive Surgery, August 2003.
“The Femtosecond Laser and The Flap.” Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes.
Differences such as predictability and measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Published:
Review of Refractive Surgery, February 2003.
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria and Hansatome microkeratomes for flap predictability,
treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“Outcomes for LASIK Performed with a Femtosecond Laser Keratome.” Authors: J. Christenbury, MD, D. Kaswinkel, MD, J. Gallo, MD. Abstract: This
retrospective study reports the 1 month postoperative clinical outcomes of 300 eyes of 156 patients who underwent laser vision correction surgery with
the IntraLase FS laser keratome. Standard outcome measurements of visual acuity, manifest refraction and intraoperative and postoperative
complications are presented and are consistent with published data for traditional LASIK. Some possible safety advantages are presented including a
reduction in dry eye complaints and data supporting the same day completion of treatment interruptions with favorable visual outcomes. Presented: 2002
American Academy of Ophthalmology. 2003 American Society of Cataract and Refractive Surgery.
“Thickness Measurements of Corneal Flaps Created with the IntraLase® FS Laser.” Authors: A. Chayet, MD, S. Litwak, MD. Abstract: This study
evaluated the thickness accuracy and predictability of corneal flaps created with the IntraLase FS laser by using subtraction pachymetry on 30 eyes of 17
patients. The mean thickness was measured at 132 ± 15 µm indicating the IntraLase FS laser creates highly accurate flaps of intended thickness which
significantly improves the safety profile of the overall procedure. Submitted: Archives of Ophthalmology, December 2002.
“Laser Creates Thin Flaps Safely.” Author: M. Gordon, MD. Abstract: This study evaluated the thickness accuracy of thin corneal flaps created with the
IntraLase® FS laser by using subtraction pachymetry on 69 eyes. The intended flap thickness was 100 µm and the mean thickness was measured at 103
± 10.5 µm. Additionally, Dr. Gordon discusses the ease of handling these thin flaps as compared to those created by a mechanical keratome. Published:
EyeWorld, November 2002.
“A Comparison of Mechanical vs. IntraLASIK® Keratectomy.” Author: H. Sloane, MD. Abstract: This retrospective study reports the clinical outcomes
of the last 100 eyes done with traditional LASIK (using a mechanical keratome) and the first 100 eyes done in the practice with the INTRALASE® FS laser
and IntraLASIK software. Early postoperative results with IntraLASIK (1 day and 1 month) were reported as good as or better than standard LASIK
results. This study suggests that a new user can quickly achieve safe and effective clinical results with the INTRALASE FS laser, results that are
equivalent or better than prior standard LASIK results. Presented: 2002 American Academy of Ophthalmology (IntraLase booth). Updated with
approximately 500 eyes at 1 month follow up and approximately 150 eyes at 6 months follow up. Presented: 2003 American Society of Cataract and
Refractive Surgery. Published: Ocular Surgery News, November 2003.
“Prospective, Randomized, Single-Center Clinical Trial of IntraLase® FS Laser vs. Hansatome® in 51 Patients Treated with CustomCornea®.”
Author: D. Durrie, MD. Abstract: This prospective, randomized study evaluated the clinical outcome of 51 patients treated with CustomCornea with an
IntraLase created flap in one eye and a Hansatome created flap in the fellow eye. Standard refractive outcomes, wavefront aberrations, dry eye
measurements and patient’s subjective evaluations will be reported. Presented: To be presented at 2003 ISRS/AAO Meeting, and in the IntraLase booth.
INTERNAL MESSAGING
Predictably Better Vision
Clinical Support:
Four different studies have evaluated the ability of the INTRALASE® FS laser to offer better visual
outcomes than those achievable with mechanical microkeratomes. The two retrospective studies
(Sloane, Stonecipher) found better astigmatic neutrality (i.e., less induction of cylinder from creation
and replacement of the flap) with the IntraLase laser. Prospective, randomized evaluations of
wavefront aberrations (Tran) determined that the IntraLase laser creates fewer higher and lower order
aberrations. In another prospective, randomized study (Durrie), patients had one eye treated with
the IntraLase laser and the fellow eye with a mechanical microkeratome. Of the patients who had a
preference, they subjectively preferred the vision with the IntraLase treated eye, and uncorrected
visual acuity was statistically better in all IntraLase treated eyes at 1 week and 1 month.
Supporting Statements:
1
IntraLase is rapidly becoming known as the key ingredient to optimizing visual results in laser
vision correction surgery. Comparative clinical studies confirm that patients see better following
laser vision correction with IntraLase than with previous methods.
2
Clinical studies show that more patients achieve 20/20 vision or better with the IntraLase laser than
with the use of the microkeratome.
3
This is better technology; a computer-controlled laser increases safety and precision and contributes
significantly to better outcomes.
4
This technology makes every laser vision correction procedure more predictable.
5
Our doctors are recommending the IntraLase laser for all of our patients. They feel this technology
significantly improves the predictability of the entire procedure, and the remarkable precision
makes any laser vision correction procedure enriched with IntraLase one of the safest forms of
surgical vision correction available today.
6
This technology allows you to choose and actually enjoy laser vision correction with confidence.
7
Our doctors can offer a new level of predictability for you in all parts of the procedure: custom
diagnosis (before the procedure), custom flap (to start the procedure), and custom treatment (to
complete the procedure).
8
According to our doctors, IntraLase is the “Essential Component of Better Vision”, making every
procedure better and more predictable.
9
Our surgeons believe that IntraLase is the essential ingredient in obtaining your best vision while
using the safest method possible.
10 Laser vision correction using IntraLase technology is more expensive than the traditional
mechanical technology. However; because of predictably better visual outcomes, our doctors are
recommending this totally customized procedure for all of our patients.
INTERNAL MESSAGING
Predictably Better Vision
Sources
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD.
Abstract: This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria® and Hansatome® microkeratomes for flap
predictability, treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“A Comparison of Mechanical vs. IntraLASIK® Keratectomy.” Author: H. Sloane, MD. Abstract: This retrospective study reports the clinical
outcomes of the last 100 eyes done with traditional LASIK (using a mechanical keratome) and the first 100 eyes done in the practice with the
INTRALASE® FS laser and IntraLASIK software. Early postoperative results with IntraLASIK (1 day and 1 month) were reported as good as or better
than standard LASIK results. This study suggests that a new user can quickly achieve safe and effective clinical results with the INTRALASE FS laser,
results that are equivalent or better than prior standard LASIK results. Presented: 2002 American Academy of Ophthalmology (IntraLase booth).
Updated with approximately 500 eyes at 1 month follow up and approximately 150 eyes at 6 months follow up. Presented: 2003 American Society of
Cataract and Refractive Surgery. Published: Ocular Surgery News, November 2003.
“Femtosecond Laser Minimizes Wavefront Distortions.” Author: Dan Tran, MD. Abstract: This prospective, randomized, single-center clinical trial
evaluated the effect of the flap on wavefront aberrations. The IntraLase® FS Laser was compared to the Hansatome® microkeratome, and standard
refractive outcomes as well as wavefront aberrations were compared after the flap was created. Submitted: Journal of Cataract and Refractive Surgery,
July 2003.
“Prospective, Randomized, Single-Center Clinical Trial of IntraLase® FS Laser vs. Hansatome® in 51 Patients Treated with CustomCornea®.”
Author: D. Durrie, MD. Abstract: This prospective, randomized study evaluated the clinical outcome of 51 patients treated with CustomCornea with an
IntraLase created flap in one eye and a Hansatome created flap in the fellow eye. Standard refractive outcomes, wavefront aberrations, dry eye
measurements and patient’s subjective evaluations will be reported. Presented: To be presented at 2003 ISRS/AAO Meeting, and in the IntraLase booth.
INTERNAL MESSAGING
Less Invasive Approach
Clinical Support:
Multiple studies attest to the IntraLase laser’s unique ability to create thinner flaps that are completely
planar (i.e. consistent thickness from edge to edge). The possibility of deep, invasive resections of the
cornea, which may occur with the traditional microkeratome device, is eliminated with the
INTRALASE® FS laser. The laser enhances, rather than restricts, the surgeon’s ability to optimally
correct highly myopic patients. The ability to leave more tissue in the stromal bed by creating a flap
of thin, but sufficient thickness, is highly valued by many surgeons who wish to preserve as much
cornea as possible for all of their patients.
Supporting Statements:
1
By replacing the traditional approach with a beam of light, the INTRALASE FS laser dramatically
reduces the risk of complications; in fact, more patients may now be candidates for laser vision
correction due to this unique level of precision that was previously unavailable.
2
Replacing the mechanical first step of the procedure with the computer precision of a laser is
consistent with many other advances in medicine today. IntraLase technology provides consistency
and precision with a tiny beam of light rather than a mechanical device that can be more invasive.
3
One of the many reasons our surgeons choose IntraLase is to avoid potential inaccuracies in the
procedure. The laser provides greater precision, safety and control, and allows us to preserve
corneal tissue.
INTERNAL MESSAGING
Less Invasive Approach
Sources
“Thickness Measurements of Corneal Flaps Created with the IntraLase® FS Laser.” Authors: A. Chayet, MD, S. Litwak, MD. Abstract: This study
evaluated the thickness accuracy and predictability of corneal flaps created with the IntraLase FS laser by using subtraction pachymetry on 30 eyes of 17
patients. The mean thickness was measured at 132 ± 15 µm indicating the IntraLase FS laser creates highly accurate flaps of intended thickness which
significantly improves the safety profile of the overall procedure. Submitted: Archives of Ophthalmology, December 2002.
“Microkeratome Use in Conventional LASIK and the Use of the IntraLase® FS Laser to Create Corneal Flaps: The All Laser Procedure.”
Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes. Differences such as predictability and
measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Presented: 2002 American Academy of
Ophthalmology (IntraLase booth). Accepted: Journal of Cataract and Refractive Surgery, August 2003.
“The Femtosecond Laser and The Flap.” Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes.
Differences such as predictability and measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Published:
Review of Refractive Surgery, February 2003.
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria® and Hansatome® microkeratomes for flap
predictability, treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
INTERNAL MESSAGING
Computer Controlled
Supporting Statements:
1
Our doctors continually evaluate advances in technology for laser vision correction. We now feel
that IntraLase technology is by far the most advanced system available, and provides a level of
predictability and consistent performance that is important for our patients.
2
Our practice is devoted to providing the highest standard of patient care. We have invested in this
technology now to maintain that level of commitment.
3
In the past we have used the traditional microkeratome technology for the first step of laser vision
correction. In the hands of our skilled surgeons, our patients have enjoyed great success and
excellent vision. However, now we are very pleased to provide the sophistication of a computerguided laser. It is much more accurate and provides greater precision, safety and control.
INTERNAL MESSAGING
100 Times More Accurate
Clinical Support:
Several clinical studies have reported a much tighter range and standard deviation of the thickness of
the flap created by the IntraLase laser when compared with mechanical microkeratomes. As Dr. Ming
Wang reported, this is very important when evaluating the risk of extremely thin or extremely thick
flaps which occur 1-2 times per 100 cases with microkeratomes (1-2%) and only 1-2 times per 100
million cases with IntraLase. A study conducted by Dr. Arturo Chayet found a significant reduction
in the probability of creating thin flaps using the INTRALASE® FS laser. For every 10,000 flaps
attempted with a microkeratome, approximately 750 will be more than 60 microns thicker or thinner
than the surgeon intended. In comparison, the INTRALASE FS laser that also performs 10,000
procedures will produce, on average, approximately 4 flaps that will be 60 microns thicker or thinner
than the surgeon intended.
Supporting Statements:
1
Clinical studies establishing the precision and accuracy of the INTRALASE FS laser have led
researchers to proclaim IntraLase technology as 100 times more accurate in creating the flap (the
first step of the LASIK procedure) than the traditional approach with a surgical blade. The
statement is founded upon comparative studies that report the likelihood of inaccuracy with the
mechanical device as compared to that of the INTRALASE FS laser.
2
Studies consistently report, and our surgeons agree, that the IntraLase laser provides a predictably
more accurate tool to perform the first step of the procedure.
3
Based on the studies that our doctors have reviewed, the computer-guided laser appears to be as
much as 100 times more accurate than any other options that are available today to perform the
very important first step of the procedure.
INTERNAL MESSAGING
100 Times More Accurate
Sources
“Thickness Measurements of Corneal Flaps Created with the IntraLase® FS Laser.” Authors: A. Chayet, MD, S. Litwak, MD. Abstract: This study
evaluated the thickness accuracy and predictability of corneal flaps created with the IntraLase FS laser by using subtraction pachymetry on 30 eyes of 17
patients. The mean thickness was measured at 132 ± 15 µm indicating the IntraLase FS laser creates highly accurate flaps of intended thickness which
significantly improves the safety profile of the overall procedure. Submitted: Archives of Ophthalmology, December 2002.
“Microkeratome Use in Conventional LASIK and the Use of the IntraLase® FS Laser to Create Corneal Flaps: The All Laser Procedure.”
Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes. Differences such as predictability and
measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Presented: 2002 American Academy of
Ophthalmology (IntraLase booth). Accepted: Journal of Cataract and Refractive Surgery, August 2003.
“The Femtosecond Laser and The Flap.” Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes.
Differences such as predictability and measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Published:
Review of Refractive Surgery, February 2003.
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria® and Hansatome® microkeratomes for flap
predictability, treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“Femtosecond Technology: Is Now the Time to Buy?” Author: Ming Wang, MD, PhD. Abstract: An examination of the clinical benefits and economic
impact of the femtosecond laser in today’s refractive surgery practice. The article presents a scientific analysis of the clinical significance of the laser’s
precision. Quoting directly from the article, “...In other words, while a microkeratome has 1-2% chance of creating a flap with extreme value of
thickness, the laser has a much reduced risk: only 1-2 x 10 - 8 percent.” Published: Refractive Eyecare For Ophthalmologists, May 2003.
INTERNAL MESSAGING
Fewer Complications
Clinical Support:
Three independent clinical studies offer strong evidence that the INTRALASE® FS laser significantly
reduces the risk of complication both during the procedure and afterwards. Dr. Karl Stonecipher
found no evidence of loose epithelium using the IntraLase laser compared with nearly 10% he
observed when using microkeratomes. Further, Drs. Nordan and Slade noted zero complications in a
very early study with over 200 procedures reported.
Supporting Statements:
1
Clinical studies have proven that by replacing the traditional mechanical device with a beam of
light, the INTRALASE FS laser dramatically reduces the risk of complications.
2
The INTRALASE FS laser enables us to provide remarkable predictability and precision. It is this
precision that makes laser vision correction enriched with IntraLase one of the safest forms of
surgical vision correction available today.
3
You can now have even more confidence in your decision for laser vision correction. The potential
to see even better than you did with glasses or contact lenses has never been greater, and the risk of
complications has never been smaller.
4
Studies have shown the incidence of dry eye symptoms may be greatly reduced with the IntraLase laser.
5
Many IntraLase surgeons report that the need to do a touch-up procedure, commonly known as an
“enhancement”, may be significantly reduced.
INTERNAL MESSAGING
Fewer Complications
Sources
“Outcomes for LASIK Performed with a Femtosecond Laser Keratome.” Authors: J. Christenbury, MD, D. Kaswinkel, MD, J. Gallo, MD. Abstract: This
retrospective study reports the 1 month postoperative clinical outcomes of 300 eyes of 156 patients who underwent laser vision correction surgery with
the IntraLase FS laser keratome. Standard outcome measurements of visual acuity, manifest refraction and intraoperative and postoperative
complications are presented and are consistent with published data for traditional LASIK. Some possible safety advantages are presented including a
reduction in dry eye complaints and data supporting the same day completion of treatment interruptions with favorable visual outcomes. Presented:
2002 American Academy of Ophthalmology. 2003 American Society of Cataract and Refractive Surgery.
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria and Hansatome microkeratomes for flap predictability,
treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“Femtosecond Laser Flap Creation: Six Month Follow-Up of Initial U.S. Clinical Series.” Authors: L. Nordan, MD, S. Slade, MD, R. Baker, OD,
C. Suarez, PhD, T. Juhasz, PhD, R. Kurtz, MD. Abstract: This prospective study reports the incidence of complications of 208 eyes of 122 patients who
underwent laser vision correction with the INTRALASE® FS laser used to create the corneal flap. Additionally, six-month postoperative clinical outcomes
from a subset of 114 patients are presented. Standard outcome measurements of visual acuity, manifest refraction and intraoperative and postoperative
complications are presented and are consistent with published data for traditional LASIK. No operative or post-operative complications were noted in
over 200 procedures. Published: Journal of Refractive Surgery; Vol 19:8-14; Jan/Feb 2003.
INTERNAL MESSAGING
One of the Safest Forms of Laser Vision Correction Available Today
Clinical Support:
Most surgeons acknowledge that the main safety issues in laser vision correction are related to the use
of the microkeratome. Multiple studies which compare the incidence of complications when using
the INTRALASE® FS laser versus the microkeratome have shown a significant decrease in the events
that adversely impact safety.
Supporting Statements:
1 LASIK surgery may be elective but good vision is not.
We understand how valuable your sight is to
you, and we keep our sights set on finding the safest and most advanced technology for our patients.
2
With IntraLase and its customization components, our surgeons can treat a wider variety of
patients, including patients with thin corneas.
3
IntraLase is the most sophisticated technology available today. Our surgeons believe that IntraLase
is more predictable, more precise and ultimately safer than the traditional approach commonly
used in the first step of the laser vision correction procedure. Our patients confirm that it has
significantly contributed to their confidence in the procedure.
4
We believe in providing the most advanced technology to our patients and are consistently the first
to do so. Leading surgeons nationwide are rapidly adopting the IntraLase technology, and
approximately 100,000 eyes have now been treated with this advanced technology. IntraLase has
become the standard of care in our practice.
5
We continually strive to increase the standard for patient care in our practice. We believe that
IntraLase – by eliminating the surgical blade – allows us to provide a more predictable and safer
procedure than we were able to offer prior to this technology.
INTERNAL MESSAGING
One of the Safest Forms of Laser Vision Correction Available Today
Sources
“Comparison of the IntraLase Femtosecond Laser and Mechanical Keratomes for LASIK.” Authors: K. Stonecipher, MD, G. Kezirian, MD. Abstract:
This retrospective analysis compares LASIK outcomes with the IntraLase® FS laser to the Moria® and Hansatome® microkeratomes for flap
predictability, treatment accuracy, and complications. Accepted: Journal of Cataract and Refractive Surgery, October 2003.
“Microkeratome Use in Conventional LASIK and the Use of the IntraLase® FS Laser to Create Corneal Flaps: The All Laser Procedure.”
Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes. Differences such as predictability and
measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Presented: 2002 American Academy of
Ophthalmology (IntraLase booth). Accepted: Journal of Cataract and Refractive Surgery, August 2003.
“The Femtosecond Laser and The Flap.” Author: P. Binder, MD. Abstract: Introduction to the differences between mechanical and laser keratomes.
Differences such as predictability and measurements of flap depth, flap diameter, flap location are discussed as well as surgical differences. Published:
Review of Refractive Surgery, February 2003.
“Thickness Measurements of Corneal Flaps Created with the IntraLase® FS Laser.” Authors: A. Chayet, MD, S. Litwak, MD. Abstract: This study
evaluated the thickness accuracy and predictability of corneal flaps created with the IntraLase FS laser by using subtraction pachymetry on 30 eyes of 17
patients. The mean thickness was measured at 132 ± 15 µm indicating the IntraLase FS laser creates highly accurate flaps of intended thickness which
significantly improves the safety profile of the overall procedure. Submitted: Archives of Ophthalmology, December 2002.
“Outcomes for LASIK Performed with a Femtosecond Laser Keratome.” Authors: J. Christenbury, MD, D. Kaswinkel, MD, J. Gallo, MD. Abstract: This
retrospective study reports the 1 month postoperative clinical outcomes of 300 eyes of 156 patients who underwent laser vision correction surgery with
the IntraLase FS laser keratome. Standard outcome measurements of visual acuity, manifest refraction and intraoperative and postoperative
complications are presented and are consistent with published data for traditional LASIK. Some possible safety advantages are presented including a
reduction in dry eye complaints and data supporting the same day completion of treatment interruptions with favorable visual outcomes. Presented:
2002 American Academy of Ophthalmology. 2003 American Society of Cataract and Refractive Surgery.
INTERNAL MESSAGING
Patient Preference
Clinical Support:
A prospective, randomized study was conducted in which patients had one eye treated with IntraLase
and the fellow eye with a traditional mechanical microkeratome. The procedure was completed with
a customized laser vision correction treatment in both eyes. At 1-month post-op visits, the majority
of patients reported that their vision in the IntraLase-treated eye was preferred to that in their
microkeratome-treated eye.
Supporting Statements:
1
In a recently conducted study, most patients preferred the visual outcome in their eye treated with
the IntraLase laser when compared to their other eye, which was treated with the traditional
mechanical device.
2
Many patients treated with the INTRALASE® FS laser tell us that when they understood that no
blade would be involved in their surgery it gave them the confidence to go forward with laser vision
correction.
Patient Preference
Source
“Prospective, Randomized, Single-Center Clinical Trial of IntraLase® FS Laser vs. Hansatome® in 51 Patients Treated with CustomCornea®.”
Author: D. Durrie, MD. Abstract: This prospective, randomized study evaluated the clinical outcome of 51 patients treated with CustomCornea with an
IntraLase created flap in one eye and a Hansatome created flap in the fellow eye. Standard refractive outcomes, wavefront aberrations, dry eye
measurements and patient’s subjective evaluations will be reported. Presented: To be presented at 2003 ISRS/AAO Meeting, and in the IntraLase booth.