VISX Candidates

CustomVue Advantage

FAQ

VISX CustomVue Procedure | Measure and Correct |
Beyond Glasses and Contacts
| Clinical Study Results |
WaveScan-driven Procedure/PreVue Lens



VISX CustomVue Laser Vision Procedure

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.

 

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. Then WaveScan technology produces a detailed map of the eye - much like a fingerprint, no two are alike. 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 your vision fairly well, but 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:

Can you briefly explain what a patient will experience during the course of this procedure?

A:

You will initially meet with the physician for an evaluation to determine if you are a good candidate for the CustomVue procedure. A WaveScan measurement will be taken to map the unique characteristics of your 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 you. Once it is confirmed that you are a good candidate, you can be scheduled for CustomVue. The physician will provide you with details on how to prepare for the day of the procedure.

If the physician feels it is beneficial, he or she may choose to provide you with a PreVue Lens during the consultation. The PreVue Lens allows you to "preview" an approximation your potential vision before the CustomVue procedure; however it is not meant to be predictive of your actual result. The physician 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 for viewing.

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 in the cornea. Your 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. Most individuals feel no pain during the procedure.

After CustomVue, you will notice results immediately, and vision will continue to improve over the next few days. Typically, you will be scheduled for a follow-up visit the next day, again in about a week, and again around a month after the initial procedure.

 

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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, University of Miami, Miami, FL
    William Culbertson, MD

  • Baylor College of Medicine, Baylor University, 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, Johns Hopkins University, Baltimore, MD
    Terrence O'Brien
    Nada Jabbur, MD

     

    Q:

    What were some of the visual acuity results?

    A:

    A significant result was that one year after the VISX CustomVue procedure:

    • 100% could pass a driving test without glasses or contact lenses
    • 98% could see 20/20 or better without glasses or contact lenses
    • 70% could see 20/16 or better without glasses or contact lenses

    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, one year after the CustomVue procedure 70% percent of clinical study participants saw 20/16 or better.

     

    Q:

    How could the CustomVue procedure affect my night vision?

    A:

    Many clinical study 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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    Beyond Glasses and Contacts

    Q:

    Will I need glasses or contacts after the CustomVue procedure?

    A:

    Probably not. One year 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.

     

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    These are not all of the clinical study results. For more information, please review the CustomVue Patient Information Booklet and Patient Information Sheet.