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First Custom Ablation Approval for Nearsightedness and Astigmatism
VISX announced on May 23, 2003 that it received approval from the U.S. Food
and Drug Administration (FDA) for CustomVue™ laser vision correction. This
wavefront ablation procedure sets a new standard for vision correction, with
the potential to enable better vision than with contacts or glasses.
The FDA approval allows for WaveScan® diagnosis and CustomVue treatment of
patients with nearsightedness and astigmatism. This approval is specifically
for wavefront-guided LASIK for correction of myopic astigmatism up to -6.00D
MRSE, with cylinder between 0.00 and -3.00D.
The CustomVue procedure tailors a unique correction for each individual. It
employs the VISX WaveScan® System, a new diagnostic system that captures a
"fingerprint" of the eye which is 25 times more precise than what was
previously measurable by standard methods for glasses and contact lenses.
WaveScan evaluates more than nearsightedness, farsightedness, and
astigmatism; it captures other, more specific imperfections in each
individual's vision. This data is then used to generate an individualized
treatment for a CustomVue procedure.
FDA clinical study data presented at the 2003 ASCRS Symposium showed that at
one year following the procedure, 98% of the clinical study participants
could see 20/20 or better UCVA, while nearly 70% had either the same or
better post-op UCVA compared to their pre-op BSCVA. A six-month evaluation
of the clinical study participants showed that four times as many
participants were very satisfied with their night vision after the VISX
CustomVue procedure, compared to their night vision before with glasses or
contacts.
"Our goal is to continue to introduce new technologies that advance laser
vision correction. We are very pleased to be the first on the U.S. market
with approval of laser vision correction for both nearsightedness and
astigmatism. We are now moving ahead with an FDA approved human clinical
study for CustomVue procedures for the treatment of farsightedness," stated
Liz Dávila, chairman and chief executive officer of VISX.
For additional information on CustomVue certification, education, treatment
card ordering, and other questions, call the VISX® Customer Response Center
at 1-800-246-VISX or 1-800-246-8479.
The Fingerprint of Your Vision™
Your vision is unique - as personal as your fingerprint or your DNA.
WaveScan® technology provides your eye doctor with a map of your vision.
WaveScan Technology
Initially you will meet with your eye doctor for a complete medical
evaluation and eye history to determine whether you are a good candidate for
the CustomVue procedure. Your doctor will discuss the benefits and risks of
the procedure with you. A WaveScan measurement will be taken to map the
unique characteristics of your vision. With this map, your doctor will be
able to:
- Accurately assess whether you're a good candidate for laser vision
correction. Anyone who is considering laser vision correction should
obtain a WaveScan measurement as the first step.
- Along with the other diagnostic tests that your doctor performs, an
individualized treatment plan can then be developed to address your unique
vision needs.
Once it is confirmed that you are a good candidate, your doctor will
schedule you for a CustomVue procedure. Your doctor will provide details to
you on how to prepare for the day of the procedure.
PreVue® Lens
If your doctor feels it is beneficial, he or she may choose to provide you
with a PreVue Lens during the consultation. The PreVue Lens enables you to
"preview" your potential vision before the CustomVue procedure. Your doctor
will place a plastic lens under the laser. Using the information from the
WaveScan, your unique correction will be placed on the lens. The lens is
then fitted in a trial frame so that you can see your potential visual
results. If a PreVue Lens is used in this evaluation, your vision through
the PreVue lens is not meant to be predictive of the end result that you
might achieve.
The CustomVue Procedure
On procedure day, you will be seated in a reclined position. Anesthetic
drops will be placed in your eyes and a flap will be created on your cornea.
Your individualized treatment information is transferred from the WaveScan
to the laser in order to drive the CustomVue procedure. The actual laser
procedure typically takes several seconds. The majority of individuals feel
no pain during the procedure.
After CustomVue, you will notice results immediately, and your vision will
continue to improve over the next few days. You will be scheduled for a
follow-up visit the next day, and again several weeks after the initial
procedure.
Please review the important information contained in the
Patient Information Sheet.
Clinical Study
Results
The U.S. Food and Drug Administration (FDA) has approved the VISX
CustomVue™ procedure as a safe and effective method for correcting
nearsightedness and astigmatism.
A significant visual acuity result of the FDA clinical study was that six
months after the VISX CustomVue™ procedure:
- 100% of participants could see well enough to legally drive a car
(20/40 or better) without glasses or contacts
- 94% of participants achieved uncorrected visual acuity of 20/20 or
better
- 74% of participants were 20/16 or better
Four times as many participants were very satisfied with their night
vision after CustomVue™, compared to their night vision with their glasses
or contact lenses.
Overall, many participants were more satisfied with their quality of vision
after the VISX CustomVue procedure than before the procedure with use of
glasses or contacts. Quality of vision refers to not only what you see, but
also how well you see under a variety of conditions, such as driving at
night.
Uncorrected visual acuity is the measurement of how well you see without
the aid of glasses or contact lenses.
WaveScanr
Technology
WaveScan technology was originally developed for use in high-powered
telescopes to reduce distortions when viewing distant objects in space. This
technology has now been applied to laser vision correction, measuring
imperfections in the eye never before measured using standard methods for
glasses and contact lenses. WaveScan-based digital technology identifies and
measures imperfections in your eyes 25 times more precisely than standard
methods. In addition, WaveScan digital information is transferred to the
laser, driving a new level of precision and accuracy.
Until now, eye doctors were forced to practice one-size-fits-all vision. An
off-the-shelf lens can correct your vision fairly well, but it does not
correct it precisely. Now, with WaveScan technology, your eye doctor can
custom tailor a correction for the unique characteristics of your vision.
PreVuer
Lens
If your doctor feels it is beneficial, he or she may choose to provide
you with a PreVue® Lens during the initial consultation. The PreVue Lens
enables you to "preview" your potential vision before the CustomVue™
procedure. Your doctor will place a plastic lens under the laser. Using the
information from the WaveScan®, your unique correction will be placed on the
lens. The lens is then fitted in a trial frame so that you can see your
potential visual results. If a PreVue Lens is used in this evaluation, your
vision through the PreVue lens is not meant to be predictive of the end
result that you might achieve.
PATIENT INFORMATION
SHEET
PRODUCT INFORMATION: VISX Wavefront-Guided LASIK for Correction of
Myopic Astigmatism (CustomVue™ LASIK Laser Treatment)
Statements regarding the potential benefits of wavefront-guided LASIK (CustomVue™)
are based upon the results of a clinical trial. These results are indicative
of not only the CustomVue treatment but also of the care of the clinical
physicians, the control of the surgical environment by those physicians, the
clinical trial’s treatment parameters and the clinical trial’s patient
inclusion and exclusion criteria. Although many clinical trial patients
after the CustomVue procedure saw 20/20 or better and/or had or reported
having better vision during the day and at night, compared to their vision
with glasses or contact lenses before the procedure, your results may vary.
You can find information about the clinical trial below and in the CustomVue
Patient Information Booklet.
Only an eye care professional trained in laser vision correction can
determine whether you are a suitable candidate for the CustomVue procedure.
As with any surgical procedure, there are risks associated with the
CustomVue treatment. Before deciding whether to have the CustomVue
procedure, you should ask your doctor for and carefully review the Patient
Information Booklet. It is important to discuss the risks associated with
the procedure and any questions you may have about the procedure with your
doctor.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES:
The VISX STAR S4™ Excimer Laser System and WaveScan WaveFront® System is
approved to perform wavefront-guided laser assisted in-situ keratomileusis
(LASIK) treatments for the reduction or elimination of myopic astigmatism up
to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D in patients 21 years
of age or older; and in patients with documented evidence of a change in
manifest refraction of no more than 0.50 D (in both cylinder and sphere
components) for at least one year prior to the date of pre-operative
examination. Note that the complete name for this ophthalmic laser is “STAR
S4 ActiveTrak™ Excimer Laser System for wavefront-guided laser assisted
in-situ keratomileusis (LASIK) treatments of myopic astigmatism up to -6.00
D MRSE, with cylinder between 0.00 and -3.00 D”. An acceptable alternate
version of this official name is “wavefront-guided LASIK for correction of
myopic astigmatism”.
Wavefront-guided LASIK is an elective procedure with the alternatives
including but not limited to eyeglasses, contact lenses, photorefractive
keratectomy (PRK), conventional LASIK, and other refractive surgeries.
Approval of the application is based on a clinical trial of 351 eyes (189
primary and 162 secondary). Of all eyes treated, 318 were evaluated for
effectiveness with 98.8% accountability at 3 months, 277 eyes with 96.9%
accountability at 6 months, 102 eyes with 95.3% accountability at 9 months,
and 86 eyes with 95.6% accountability at 12 months. The studies found that
of the 277 eyes eligible for the uncorrected visual acuity (UCVA) analysis
of effectiveness at 6 months, 100 % were corrected to 20/40 or better, and
95.8 % were corrected to 20/20 or better in 71 spherical myopia eyes; and
99.5 % were corrected to 20/40 or better, and 93.2 % were corrected to 20/20
or better in 206 astigmatic myopia eyes.
The study showed that at the 3 month stability time point: there was a loss
of ≥ 2 lines of best corrected vision that can be obtained with spectacles
in 1 of 239 astigmatic myopia eyes and there was no loss of ≥ 2 lines of
best corrected vision in 79 spherical myopia eyes; there was 1 of 239
astigmatic myopia eyes with best spectacle corrected visual acuity (BSCVA)
worse than 20/25 and none in 79 spherical myopia eyes with BSCVA worse than
20/25. During the course of study, no eye lost >2 lines of BSCVA and no eye
had a BSCVA worse than 20/40.
CONTRAINDICATIONS:
Wavefront-guided LASIK is contraindicated in patients with collagen
vascular, autoimmune or immunodeficiency disease, signs of keratoconus or
abnormal corneal topography, patients taking isotretinoin (Accutane®*) or
amiodarone hydrochloride (Cordarone®†) or are pregnant or nursing.
WARNINGS:
Wavefront-guided LASIK is not recommended in patients who have diabetes, a
history of Herpes simplex or Herpes zoster keratitis, significant dry eye
that is unresponsive to treatment, or severe allergies. Lower uncorrected
visual acuity may be anticipated in the treatment of higher degrees of
myopia with and without astigmatism (>-5.0 D MRSE).
PRECAUTIONS:
The safety and effectiveness of wavefront-guided LASIK surgery has ONLY been
established with an optical zone 6 mm and an ablation zone of 8 mm. Long
term risks of wavefront-guided LASIK for myopic astigmatism beyond 12 months
have not been studied. The safety and effectiveness of STAR S4 Excimer Laser
System have NOT been established for wavefront-guided surgery in patients:
whose WaveScan-measured pupil size is less than 6 mm; for treatments greater
than -6 diopters of MRSE or with greater than 3 diopters of astigmatism and
for retreatment with CustomVue™ LASIK.
Although the WaveScan WaveFront System measures the refractive error and
wavefront aberrations of the human eyes, including myopia, hyperopia,
astigmatism, coma, spherical aberration, trefoil, and other higher order
aberrations through sixth order, in the clinical study for this PMA, the
average higher order aberration did not decrease after CustomVue treatment.
It is possible, after wavefront-guided LASIK treatment, that patients will
find it more difficult than usual to see in conditions such as very dim
light, rain, snow, fog, or glare from bright lights at night. Visual
performance possibly could be worsened by large pupil sizes or decentered
pupils. Pupil size should be evaluated under mesopic illumination
conditions.
ADVERSE EVENTS AND COMPLICATIONS:
The clinical trial showed that the following adverse events or complications
occurred in at least 1% of the 351 eyes at any interval up to 6 months
post-treatment: inflammation of the cornea under the flap (1.4%); double or
ghost images (1.4%); and scratch on the surface of the eye (1.4%).
The following subjective symptoms frequency rated “often or always” were
increased in the effectiveness cohort at 6 months post-treatment on 258 eyes
compared with pre-treatment on 332 eyes: dryness (9 % vs. 6%); fluctuation
of vision (3% vs. 2%); glare (4 % vs. 2 %) and halos (7 % vs. 5 %).
* Accutane® is a registered trademark of Hoffmann-La Roche Inc.
† Cordarone® is a registered trademark of Sanofi-Synthelabo, Inc.
Information courtesy of:
http://www.personalbestvision.com/ |
