VISX CustomVue™
Laser Vision Procedure
What is VISX
CustomVue (individualized laser vision) correction?
Who is a candidate for VISX CustomVue
procedure?
What is Personal Best Vision?
What is WaveScan® technology?
What is WaveScan® technology?
How is the
information transferred from the WaveScan to the laser?
Can you briefly explain what a
patient will experience during the course of this procedure?
Will I need glasses or contacts
after the CustomVue™ procedure?
How many sites were included in the
FDA clinical study and where are they?
What were the visual acuity results
of the FDA clinical study?
What does better than 20/20 mean?
How could the CustomVue™ procedure
affect my night vision?
Why is WaveScan technology so important to the CustomVue™ procedure?
What is the PreVue Lens?
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Q: What is VISX CustomVue (individualized
laser vision) correction?
A: VISX CustomVue individualized laser vision
correction is WaveScan®-driven, which, enables the physician to measure
and correct unique imperfections in each individual's vision. Many of
these imperfections could never be measured before using standard methods
for glasses and contact lenses.
Q: Who is a candidate for VISX CustomVue procedure?
A: If you are 21 years of age or older and wear glasses
or contacts to correct nearsightedness and/or astigmatism you may benefit
from CustomVue™. If you meet the criteria, you should see your eye
doctor for more information.
Q: What is Personal Best Vision?
A: Because every individual's eyes are unique, each
individual may benefit from a correction custom-tailored for them. For
the first time, CustomVue using WaveScan technology can measure and correct
the unique characteristics of each individual's vision, potentially providing
them with the best possible vision for their eyes, or their Personal Best
Vision.
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Measure and Correct
Q: What is WaveScan® technology?
A: 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 an individual's eye
25 times more precisely than standard methods. Physicians use this information
to treat individuals with the CustomVue™ procedure.
Q: Why is WaveScan technology so important to the
CustomVue procedure?
A: Until now, physicians were forced to practice one-size-fits-all
vision. An off-the-shelf lens corrects an individual's vision fairly well,
but it does not correct it precisely because it is not uniquely tailored
to that person's fingerprint of vision. Now, with WaveScan technology,
we can custom tailor a correction for the unique characteristics of each
individual's vision.
Q: How is the information transferred from the WaveScan to the laser?
A: The WaveScan digital information is transferred
to the laser, providing a new level of precision and accuracy.
Q: Can you briefly explain what a patient will
experience during the course of this procedure?
A: The individual will initially meet with the physician
for an evaluation to determine if he or she is a good candidate for the
CustomVue procedure. A WaveScan measurement will be taken to map the unique
characteristics of his or her vision. The physician will assess several
criteria including level of correction, and overall eye health and discuss
the benefits and risks of the procedure with the patient. Once it is confirmed
that the individual is a good candidate, he or she can be scheduled for
CustomVue. The physician will provide details for the individual on how
to prepare for the day of the procedure.
If the physician feels it is beneficial, he may choose to
provide the patient with a PreVue® Lens during the consultation. The
PreVue Lens allows an individual to "preview" their potential
vision before the CustomVue procedure. The physician will place a plastic
lens under the laser. Using the information from the WaveScan, the individual's
unique correction will be placed on the lens. The lens is then fitted
in a trial frame for viewing. 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.
On procedure day, the individual will be seated in a reclined
position. Anesthetic drops will be placed in the eyes and a flap will
be created in the cornea. The individual's treatment information is transferred
from the WaveScan to the VISX® 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, individuals will notice results immediately,
and vision will continue to improve over the next few days. The individual
will be scheduled for a follow-up visit the next day, and again several
weeks after the initial procedure.
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Beyond Glasses and Contacts
Q: Will I need glasses or contacts after the CustomVue™ procedure?
A: Probably not. Six months after the clinical study,
all participants saw well enough to drive a car without glasses or contacts.
Ninety-four percent had 20/20 vision. However, individual results may
vary.
Clinical Study Results
Q: How many sites were included in the FDA clinical
study and where are they?
A: Six sites participated in the FDA clinical study
at the following locations:
Bascom-Palmer Eye Institute, Miami,
FL
William Culbertson, MD
Baylor College of Medicine,
Houston, TX
Douglas Koch, MD
Coleman Vision, Albuquerque,
NM
Stephen Coleman, MD
Kraff Eye Institute,
Chicago, IL
Colman Kraff, MD
Maloney Vision Institute,
Los Angeles, CA
Robert Maloney, MD
Wilmer Eye Institute,
Baltimore, MD
Terrence O'Brien
Nada Jabbur, MD
Q: What were the visual acuity results of the FDA
clinical study?
A: A significant result was that six months after the VISX CustomVue™
procedure:
100% of participants could pass a driving test without glasses or contacts
94% of participants could see 20/20 or better without glasses or contacts
74% of participants could see better than 20/20 without glasses or contacts
Q: What does better than 20/20 mean?
A: 20/20 is the current standard for excellence in
vision. But, with the CustomVue™ procedure, individuals have the
potential to see even better than 20/20. In fact, six months after the
CustomVue procedure more than 74% percent of clinical study participants
saw 20/16 or better.
Q: How could the CustomVue™ procedure affect
my night vision?
A: Many patients found their night vision was improved
after the CustomVue procedure. In fact, in the clinical study, four times
as many participants were very satisfied with their night vision after
the procedure as compared to their night vision before with glasses or
contacts.
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WaveScan®-driven Procedure/PreVue® Lens
Q: Why is WaveScan technology so important to the CustomVue™ procedure?
A: For the first time, WaveScan technology captures
unique imperfections in each individual's vision that could not have been
measured before using standard methods for glasses and contact lenses.
This new level of measurement provides 25-times more precision than standard
measurements for glasses and contact lenses. Then, WaveScan technology
produces a detailed map of the eye - much like a fingerprint, no two are
alike. And, WaveScan digital information is transferred to the laser,
providing a new level of precision and accuracy.
Q: What is the PreVue Lens?
A: The PreVue Lens allows individuals to test drive
their potential new vision before undergoing the procedure. Once the WaveScan
measurement is taken, the physician will place a plastic lens under the
VISX® laser. The individual's unique correction will be placed on
the lens, then the lens will be fitted in a trial frame for viewing. The
PreVue Lens is not a requirement for the CustomVue procedure. Your physician
will decide if this tool is beneficial for each individual. 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.
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