FDA Approved

Breaking down the boundaries of laser vision correction surgery, the Advanced CustomVue procedure has the broadest range of wavefront guided approvals, with an unprecedented level of precision and accuracy. The procedure leverages Iris Registration, Fourier algorithms, VSS and VRR technologies, and 3D ActiveTrak to ensure precise ablation. Now, more than 94 percent of the population in the U.S. and 99.75 percent outside the U.S. are potentially eligible to benefit from laser vision correction surgery.

More Precise Measurements

Only the Advanced CustomVue procedure with the proprietary AMO Fourier algorithm offers the highest resolution of wavefront error. Hartmann-Shack technology and Fourier analysis enable treatment based on approximately 240 data points across a patient's pupil. Access to precise data enables the treatment of both higher- and lower-order aberrations with extremely high success rates, delivering a potentially superior vision correction alternative to glasses and contact lenses for eligible vision correction candidates.

The Most FDA Approvals

In another industry first, AMO's Advanced CustomVue  procedure is now the only FDA-Approved Wavefront-guided laser vision correction treatment for the correction of both near and distance vision of presbyopic patients.
The Advanced CustomVue procedure provides a full range of treatments for patients who have all forms of astigmatism, whether associated with nearsightedness, farsightedness or mixed astigmatism. The Advanced CustomVue procedure has the broadest FDA-approved, custom wavefront-guided treatments available today for individuals with myopia and hyperopia with or without astigmatism. This procedure has been approved for treating:

• Myopia — up to 11.0 diopters of correction, with or without astigmatism up to -3 diopters
• Hyperopia — up to 3 diopters of correction with or without astigmatism up to +2 Diopters
• Mixed astigmatism up to 5 diopters
• Monovision — retention of up to -2.0 D of myopia in the non dominant eye of patients with myopia up to -6.0 D and astigmatism up to -3.0 D

Excellent Outcomes for Broadest Range of Treatments

Results from multi-center clinical studies demonstrate that the Advanced CustomVue procedure enables excellent outcomes for the broadest range of FDA-approved wavefront-guided treatments:

• Low to Moderate Myopia: In clinical studies, 100 percent of patients treated for moderate myopia could pass a driving test without glasses or contact lenses, and 98 percent had 20/20 vision or better one year after treatment.
• Hyperopia: Four times as many participants were very satisfied with their vision after the procedure, compared to their vision before the procedure with glasses and contact lenses.
• Mixed Astigmatism: Three months after the Advanced CustomVue procedure, 100 percent of eyes treated for mixed astigmatism showed either a decrease or a change of less than or equal to 0.1 microns of higher-order RMS.
• High Myopia: Only 2.2 percent of eyes in the high myopia clinical trial required re-treatment. The High Myopia study was the first to utilize Fourier algorithms to construct treatment plans.
• Monovision: 12 months after the multi-center clinical trial, 98% of patients expressed satisfaction with the results, and if given the choice, would elect to have the Advanced CustomVue Monovision procedure again.

Clearer Night Vision: For all indications submitted to the FDA, satisfaction with night vision improved after the CustomVue procedure.

Four Steps to Success

The Advanced CustomVue procedure consists of the following four steps:

1. Acquire: Data on the patient's wavefront error is collected with the AMO WaveScan WaveFront System.
2. Design: A customized treatment is designed using the data collected on the unique characteristics of the patient's eye with unique proprietary algorithms.
3. Align: The treatment is aligned to the patient's eye using Iris Registration technology, which links diagnostic information to the treatment delivered during the Advanced CustomVue procedure.
4. Deliver: Using VSS and VRR technologies ensures the intricate shapes reconstructed by the Fourier wavefront algorithm are precisely ablated by the STAR S4 IR Excimer Laser System.

Acquire comprehensive, reliable wavefront data
Design the optimal ablation shape for each individual eye
Align and orient this optimal shape to the patient’s cornea
Deliver the intended shape, utilizing precise and efficient laser technology

Acquire

Acquiring comprehensive wavefront data is the first step in the CustomVue procedure. Advanced WaveScan software enables you to capture wavefront information out to 7mm with a transition zone that is adjustable out to 9.5mm. WaveScan utilizes the wavefront measurement and the patient's K-values to create the optimal corneal shape for each individual.

The WaveScan WaveFront System provides:

Acuity Maps®

Chart the optical aberrations of the eye.

Difference Maps
 
Track the changes of the eye for pre-op and post-op comparisons. 

Point Spread Function (PSF)
 
Demonstrates how a patient would see a point source of light.

Design Designing truly individualized treatment is the second step in the CustomVue procedure. The VISX Fourier Wavefront Upgrade enables you to calculate more precise ablation shapes than ever before, creating extensive individualized treatment possibilities. This proprietary algorithm utilizes all available Hartmann-Shack data points to achieve a new level of reconstruction accuracy, equivalent to 20th order Zernike. 

The above images represent the wavefront shapes that are derived from the available data points. The Fourier algorithm offers greater fidelity and thus creates a shape that more closely matches the eye's actual wavefront error. Combining this unprecedented definition with the ability to adjust the optical and ablation zones, the powerful WaveScan software creates a custom tailored correction map for the unique characteristics of each individual eye. 

Align

Aligning the treatment plan to the patient's eye is the important third step in the CustomVue procedure. The STAR S4 with Iris Registration and Activetrak help you maintain centered ablations with our exclusive alignment technologies:

IRIS REGISTRATION: A NEW LEVEL OF PRECISION

VISX Technology Iris Registration (IR) is the first FDA-approved, fully automated method of aligning and registering wavefront corrections for the Advanced CustomVue™ treatment.

It's normal for the pupil to shift from the time an eye is measured to the time of treatment. Iris Registration is an alignment method that provides greater accuracy and, unlike commonly used ink-based methods in which the eye is literally marked with a pen; IR is not time sensitive, leaving the physician free to take their time without having to be concerned with re-registering the treatment should the ink markings dissolve. An obvious advancement over standard alignment practices, IR achieves cyclotorsional alignment by automatically linking a patient's diagnostic information with the laser treatment. IR then centers the treatment correctly, independent of changes in the pupil center from measurement to treatment.

All of this translates to more peace of mind for you, the patient, as you can rest assured that any movement of your eye during the procedure will not jeopardize either the accuracy of the treatment or your safety.

Features:

• Greater alignment accuracy
• Non-contact method of aligning treatment
• Images iris under flap
• Re-registration capability during treatment

Benefits:

• Achieves cyclotorsional alignment by linking diagnostic 
  information with laser treatment
• Creates a new level of confidence in the accurate placement of the correct treatment on the patient’s eye
• Minimizes human error in aligning treatment
• Provides the physician with the ability to compensate for intra-operative cyclotorsional movement

3-D active eye tracking 
Tracks x, y, and z axis intra-operative movement of the eye

ActiveTrak Automatic Centering 
Locates, and then automatically sets the treatment center to the center of the pupil. 

1.5mm passive limits 
If the patient's eye moves 1.5 mm from the established center point in any direction, the tracker pauses the laser, resuming only after the eye has returned to within acceptable limits. 

Virtual reticle 
A virtual grid overlay on the eye provides real-time, dynamic feedback to allow you to monitor treatment progress and eye position. 

Delivering the individualized ablation shape to the patient's cornea is the final step in the CustomVue procedure.

Deliver

Variable Spot Scanning with Variable Repetition Rate

Indications

Treat More Patients 

The VISX CustomVue procedure now provides the broadest range of U.S. FDA approved wavefront-guided laser vision correction treatments for your patients including: 

• Myopia with and without Astigmatism
• Hyperopia with and without Astigmatism
• Mixed astigmatism

 
As shown in FDA clinical studies, the CustomVue procedure may improve vision beyond the correction possible with contact lenses or glasses