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.

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.

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.

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:

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:

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.

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.Please review the important information contained in the Patient Information Sheet.