VISX CustomVue Laser Vision Procedure
What is VISX CustomVue (individualized laser vision) correction?
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.
Who is a candidate for VISX CustomVue procedure?
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.
What is WaveScan 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 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.
Why is WaveScan technology so important to the CustomVue procedure?
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.
back to top
Can you briefly explain what a patient will experience during the course of this procedure?
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.
Clinical Study Results
How many sites were included in the FDA clinical study and where are they?
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
back to top
What were some of the visual acuity results?
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
What does better than 20/20 mean?
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.
How could the CustomVue procedure affect my night vision?
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.
Beyond Glasses and Contacts
Will I need glasses or contacts after the CustomVue procedure?
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.
What is the IntraLase Method™?
The IntraLase Method is a 100% blade-free technique used to perform the critical first step in the LASIK procedure: creating the corneal flap. The creation of the corneal flap prepares the eye for the second step of the LASIK procedure, where an excimer laser is used on the inner cornea to correct vision.
back to top
How does the IntraLase Method work?
The IntraLase Method uses tiny, rapid pulses of laser light to create your corneal flap—instead of using a metal blade—during the first step of LASIK. Each pulse of light passes through the top layers of your cornea and forms a microscopic bubble at a specific depth and position within your eye that is determined by the doctor. The IntraLase® laser moves back and forth across your eye, creating a uniform layer of bubbles just beneath your corneal surface.
Just prior to applying laser vision correction, the doctor creates your corneal flap by gently separating the tissue where these bubbles have formed. The corneal flap is then folded back so the doctor can perform the second step of your LASIK treatment.
What is the difference between a corneal flap created with the IntraLase Method and one created with a microkeratome?
The microkeratome is a hand-held instrument, which contains a steel blade that moves back and forth and creates a cut as it travels across the cornea. A microkeratome is only capable of making a single, one-dimensional cut across the cornea. As it cuts, the blade oscillates back and forth, which can leave an irregular surface after the flap is lifted. This can affect the quality of your postoperative vision. Because of the unique way in which the IntraLase Method creates a precisely positioned layer of bubbles just beneath the surface of your eye, it creates a smooth even surface after your flap is lifted. With the IntraLase Method, a blade never touches your eye.
How is the IntraLase Method different from Epi-LASIK or photo-refractive keratectomy (PRK)?
These procedures differ from one another in the way they prepare the surface of the cornea for the second step of LASIK. Epi-LASIK uses an epikeratome—a blunt separator—to make a superficial flap. Similarly, photo-refractive keratectomy (PRK) is performed by gently scraping the surface layer of the cornea, which may lead to corneal scarring. Both the Epi-LASIK and PRK procedures can be painful and require more postoperative medication. In addition, healing times may be longer than with procedures performed with the IntraLase Method.
back to top
Are there other benefits to using the IntraLase Method?
There are several benefits to using the IntraLase Method:
- Better vision. More patients in clinical trials achieved vision that was 20/20 or better when their LASIK procedure was performed with the IntraLase Method.(1) And patients report better quality of vision overall, particularly in terms of their ability to see well in low light such as at dusk or at night.(2)
- Ability to tailor the procedure to your eye. The IntraLase Method gives your doctor the ability to tailor the dimensions of your corneal flap based on what’s best for your eye. Everything from the diameter of your flap to the angle of its edges can be precisely determined. This is important because everyone’s eyes are shaped a little differently. Having a corneal flap that’s individualized to the patient contributes to excellent postoperative outcomes. In addition, a corneal flap created with the IntraLase Method also “locks” back into position after the LASIK procedure is performed.
Is the IntraLase Method painful?
Prior to creating the flap, the doctor applies drops to numb the eye, and then applies a special ring and an instrument that gently flattens your cornea in preparation for the IntraLase Method. This part of the process is not painful—patients report feeling only slight pressure.
Is the IntraLase Method safe?
More than 600,000 procedures have been performed safely and effectively using the IntraLase Method.
How long does it take to create a flap using the IntraLase Method?
The creation of the flap itself takes only about 15-30 seconds per eye. Including preparation time, the entire LASIK procedure takes about 10 minutes.
back to top
What's the reaction of patients who have experienced the IntraLase Method?
In a clinical survey of LASIK patients who had their corneal flaps created using a microkeratome in one eye and the IntraLase Method in the other, the vision in the IntraLase-treated eye was preferred 3-to-1 (among those who stated a preference).(3)
Is the IntraLase Method right for me?
If you are looking for a 100% blade-free LASIK experience that virtually eliminates almost all the most severe, sight-threatening complications, the answer is yes. But to get this procedure, you have to ask your physician for the IntraLase Method™ by name.
What is the IntraLase Method™?
The IntraLase Method is a 100% blade-free technique used to perform the critical first step in the LASIK procedure: creating the corneal flap. The creation of the corneal flap prepares the eye for the second step of the LASIK procedure, where an excimer laser is used on the inner cornea to correct vision.
back to top
How does the IntraLase Method work?
The IntraLase Method uses tiny, rapid pulses of laser light to create your corneal flap—instead of using a metal blade—during the first step of LASIK. Each pulse of light passes through the top layers of your cornea and forms a microscopic bubble at a specific depth and position within your eye that is determined by the doctor. The IntraLase® laser moves back and forth across your eye, creating a uniform layer of bubbles just beneath your corneal surface.
Just prior to applying laser vision correction, the doctor creates your corneal flap by gently separating the tissue where these bubbles have formed. The corneal flap is then folded back so the doctor can perform the second step of your LASIK treatment.
What is the difference between a corneal flap created with the IntraLase Method and one created with a microkeratome?
The microkeratome is a hand-held instrument, which contains a steel blade that moves back and forth and creates a cut as it travels across the cornea. A microkeratome is only capable of making a single, one-dimensional cut across the cornea. As it cuts, the blade oscillates back and forth, which can leave an irregular surface after the flap is lifted. This can affect the quality of your postoperative vision.
Because of the unique way in which the IntraLase Method creates a precisely positioned layer of bubbles just beneath the surface of your eye, it creates a smooth even surface after your flap is lifted. With the IntraLase Method, a blade never touches your eye.
How is the IntraLase Method different from Epi-LASIK or photo-refractive keratectomy (PRK)?
These procedures differ from one another in the way they prepare the surface of the cornea for the second step of LASIK. Epi-LASIK uses an epikeratome—a blunt separator—to make a superficial flap. Similarly, photo-refractive keratectomy (PRK) is performed by gently scraping the surface layer of the cornea, which may lead to corneal scarring. Both the Epi-LASIK and PRK procedures can be painful and require more postoperative medication. In addition, healing times may be longer than with procedures performed with the IntraLase Method.
back to top
Are there other benefits to using the IntraLase Method?
There are several benefits to using the IntraLase Method:
- Better vision. More patients in clinical trials achieved vision that was 20/20 or better when their LASIK procedure was performed with the IntraLase Method.(1) And patients report better quality of vision overall, particularly in terms of their ability to see well in low light such as at dusk or at night.(2)
- Ability to tailor the procedure to your eye. The IntraLase Method gives your doctor the ability to tailor the dimensions of your corneal flap based on what’s best for your eye. Everything from the diameter of your flap to the angle of its edges can be precisely determined. This is important because everyone’s eyes are shaped a little differently. Having a corneal flap that’s individualized to the patient contributes to excellent postoperative outcomes. In addition, a corneal flap created with the IntraLase Method also “locks” back into position after the LASIK procedure is performed.
Is the IntraLase Method painful?
Prior to creating the flap, the doctor applies drops to numb the eye, and then applies a special ring and an instrument that gently flattens your cornea in preparation for the IntraLase Method. This part of the process is not painful—patients report feeling only slight pressure.
Is the IntraLase Method safe?
More than 600,000 procedures have been performed safely and effectively using the IntraLase Method.
back to top
How long does it take to create a flap using the IntraLase Method?
The creation of the flap itself takes only about 15-30 seconds per eye. Including preparation time, the entire LASIK procedure takes about 10 minutes.
What's the reaction of patients who have experienced the IntraLase Method?
In a clinical survey of LASIK patients who had their corneal flaps created using a microkeratome in one eye and the IntraLase Method in the other, the vision in the IntraLase-treated eye was preferred 3-to-1 (among those who stated a preference).(3)
Is the IntraLase Method right for me?
If you are looking for a 100% blade-free LASIK experience that virtually eliminates almost all the most severe, sight-threatening complications, the answer is yes. But to get this procedure, you have to ask your physician for the IntraLase Method™ by name.
back to top |
