iLASIK Technology

The 3 essential technologies a decade in the making!

A) Advanced CustomVue™ System

Breaking down the boundaries

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.*

*Market Scope Data, U.S. Vision Population, 21 years of age or older, 2005

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.

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

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.

B) IntraLase™ FS Laser Technology

The 4th Generation IntraLase® FS Laser:
Speed, Biomechanical Stability, Precision, and Safety

At a nearly unprecedented level, LASIK has become a trusted way for people to improve their functional vision. And judging by the numbers, the IntraLase Method, using our new IntraLase™ FS Technology, has become an integral part of today's advanced LASIK procedure. With well over 1 million procedures completed to date, IntraLase™ FS Technology is clearly in the DNA of our successful practice. This link between IntraLase™ FS Laser System and our LASIK practice exists because:

• Our patients want blade-free all-laser LASIK, and we're the all-laser pioneers
• Surgeons believe in the safety, and effectiveness of the IntraLase™ FS laser
• The future of refractive surgery hinges on the innovative application of scientific breakthroughs, and IntraLase™ FS Technology is at the forefront

How does the IntraLase™ FS Technology contribute to our LASIK success? By delivering biomechanical superiority, excellent visual acuity, and unmatched safety. This innovative technology is also well suited for creating uniquely shaped corneal incisions for corneal transplant surgery.

Blade-free IntraLase Advantages over a Bladed LASIK

The 4th Generation IntraLase laser works with microkeratome speed and laser precision. Corneal flap creation is faster and better than ever. This technology preserves biomechanical stability, increases precision, enhances LASIK safety, and improves outcomes of the LASIK procedure.(1-4)

A: Faster procedure time (click here to see just how fast it is)

• The 4th Generation IntraLase FS laser works with the speed of a microkeratome*(1)

B: Predictability and control

• Better biomechanical stability vs. a microkeratome(2)

C: Precision to improve outcomes

• Better early visual outcomes vs. a microkeratome(3)
• Better refractive outcomes vs. a microkeratome(4)
• Better early contrast acuity recovery vs. a microkeratome(3)

D: Greater safety

• Lower induced high-order aberrations vs. a microkeratome(4)
• Less induction of astigmatism vs. a microkeratome(4)
• Less induced dry eye vs. a microkeratome(5)
• Fewer retreatments vs. procedures performed with a microkeratome(6)

*Fast refers to procedure time and is defined as the time from device setup to the moment the corneal bed is ready for ablation.(1)

Reference:
1.Davis E. Data on file, IntraLase Corp. 2006.
2.Alió JL, Ortiz D, Piñero D. Flap biomechanics with femtosecond and mechanical microkeratomes. Data presented at: European Society of Cataract and Refractive Surgeons; September 10-14, 2005; Lisbon, Portugal.
3.Tanzer DJ, Schallhorn SC, Brown MC, et al. Comparison of visual outcomes with femtosecond and mechanical microkeratomes for wavefront-guided LASIK. Data presented at: Joint Meeting of the American Academy of Ophthalmology & the International Society of Refractive Surgery; October 23, 2004; New Orleans, La; October 14, 2005; Chicago, Ill.
4.Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided in situ keratomileusis. J Cataract Refract Surg. 2005:31;120-126.
5.Shamie N. Post-LASIK Corneal Hypoesthesia and Dry Eye. Data presented at: Congress of the American Society of Cataract & Refractive Surgery; April 12-16, 2003; San Francisco, Calif.
6.Manger C. Enhancement Rates of IntraLase Laser and microkeratome-assisted LASIK. Data presented at: Congress of the American Society of Cataract & Refractive Surgery; May 2, 2004; San Diego, Calif.

Precision Technology for a Safer LASIK experience

By replacing the blade commonly used for corneal flap creation with a femtosecond laser, the blade-free IntraLase has made LASIK eye surgery much safer than ever before. The IntraLase™ FS Laser System delivers micron-level accuracy 100% greater1,2 than a microkeratome for more accurate and consistent flap thickness — which is critical for a successful LASIK outcome.

Retrospective analysis comparing LASIK results with IntraLase™ FS Technology versus the two leading microkeratomes demonstrated that IntraLase™ FS Laser System performed better in three areas important to LASIK results and safety: flap thickness, induced astigmatism, and cell injury.3

There are fewer flap-related complications with the IntraLase Method:*4

• Minimal risk of sight-threatening events (free caps, globe penetration, buttonhole flaps, decentered flaps, and/or incomplete cuts)
• No risk of corneal abrasion
• Reduced risk of dry eye

*Only the IntraLase™ FS Laser System can be used to perform the IntraLase Method.

1. Wang M. Femtosecond technology: Is now the time to buy? Refractive Eyecare for Ophthalmologists. May 2003;5:7.
2. Talamo JH. Optimizing flap outcomes with the IntraLase™ FS laser. Ophthalmol Management. May 2004.
3. Kezirian GM, Stonecipher KG. Comparison of the IntraLase™ femtosecond laser and mechanical keratomes for laser in situ keratomileusis. J Cataract Refract Surg. 2004;30(4):804-811.
4. Will B, Kurtz RM. IntraLase™ is best. In: Probst LE, ed. LASIK: Advances, Controversies, and Custom. Thorofare, NJ: SLACK; 2004:397-402.

There's Only One IntraLase™ FS Laser System

Increasingly, successful LASIK procedures have one thing in common — they use IntraLase™ FS Laser System. IntraLase™ FS Technology clearly delivers clinical advantages to enhance our results:

• Our 4th-generation laser is designed as a primary laser for LASIK procedures and advanced corneal surgery procedures
• 60 kHz performance delivers microkeratome speed and laser precision
• Better biomechanical stability vs. a microkeratome (1)
• Lower induced high-order aberrations vs. a microkeratome (2)
• Better refractive outcomes vs. a microkeratome (2)

*Through three months postoperative

1. Alió JL, Ortiz D, Piñero D. Flap biomechanics with femtosecond and mechanical microkeratomes. Data presented at: European Society of Cataract and Refractive Surgeons; September 10-14, 2005; Lisbon, Portugal.
2. 2. Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided in situ keratomileusis: prospective contralateral eye study. J Cataract Refract Surg. 2005;31(1):120-126.

Biomechanically Superior Flap Creation

Maintaining the integrity of the corneal biomechanics is a critical element in the success of the refractive procedure — and only AMO IntraLase™ FS Laser System delivers unmatched control over flap diameter, depth, centration and morphology, resulting in an unprecedented combination of potential advantages, including:

• Controlled Flap Structure
  • Precisely centered, accurately sized flaps; programmable hinge placement1
  • Flap dimensions designed based on patient factors, such as corneal thickness, steepness, diameter and pupil position
  • Precise control of flap dimensions helps avoid the peripheral lamellar structure, vital to the biomechanical stability of the cornea2
• Uniform Flap Thickness
  • Uniformly thin, planar flaps3
  • Smooth, evenly hydrated, stromal morphology4
  • Reproducible flap thicknesses with profiles that are significantly superior to those achieved by mechanical means (p<0.001)4
  • Maximized residual stromal beds
• Superior Visual Outcomes
  • Rapid visual recovery
    • Day 1: UCVA 20/16 or better in 70% of patients (n=199)5
    • Month 1: Increased contrast sensitivity at all spatial frequencies vs. baseline (n=88)6
  • Better quality of vision
    • Eyes treated with the IntraLase FS Laser System had fewer visual disturbances (haze, glare, sensitivity), less pain, and less dryness than a microkeratome6

INTRALASE FS (9x)	INTRALASE FS (135x)	INTRALASE FS (300x)
ZYOPTIX XP (9x)	ZYOPTIX XP (135x)	ZYOPTIX XP (300x)

Reference:
1.Data on file, IntraLase Corp.
2.Prof. John Marshall. Sub-Bowman's Keratomileusis vs. PRK. Data presented at: Winter European Society of Cataract and Refractive Surgeons; February 2-4, 2007.
3.Binder PS. Flap dimensions created with the IntraLase FS Laser. J Cataract Refract Surg. 2004;30(1):26-32.
4.Kezirian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis. J Cataract Refract Surg. 2004;30(4):804-811.
5.Tanzer DJ, Schallhorn S, Brown MC, et al. Comparison of femtosecond vs. mechanical keratome in wavefront-guided LASIK. Data presented at: American Society of Cataract and Refractive Surgery Symposium; April 15-20, 2005; Washington, DC.
6.Durrie D. A randomized, prospective clinical study of LASIK performed with the IntraLase FS laser vs. mechanical microkeratome. Data presented at: American Academy of Ophthalmology; October 23-26, 2004; New Orleans, LA.

Faster Visual Acuity Return

In a recent study (Sub-Bowman's Keratomileusis with IntraLase™ FS Laser System vs. PRK), IntraLase treated eyes demonstrated clinically and statistically better visual acuities (uncorrected and best corrected) through one month post-op compared to surface treatment.1

• Uncorrected Vision
  • Through one week postop, eight times more IntraLase eyes achieved 20/20 or better uncorrected vision compared to PRK eyes1
  • Superiority continued at one month, where 45% more IntraLase eyes achieved 20/20 or better uncorrected vision compared to PRK eyes1
• Best Corrected Vision
  • Clinically and statistically significant improvement through one month with LASIK with the IntraLase Method over PRK when comparing baseline BCVA and post-op BCVA1
  • At one month, more than twice as many IntraLase eyes showed BCVA gain compared to PRK eyes1

C) STAR S4 IR™ Excimer Laser System

The STAR S4 IR™ Excimer Laser System is designed to bring Advanced CustomVue™ laser vision correction to life. Featuring Variable Spot Scanning (VSS™) and Variable Repetition Rate (VRR™) pulse-packing algorithm, both proprietary to AMO, the STAR S4 IR™ Excimer Laser reduces thermal effects on the cornea, allowing you to perform the Advanced CustomVue procedure quickly and effectively, while maximizing patient safety.

Using the STAR S4 IR™ Excimer Laser System, surgeons can deliver the broadest range of wavefront-guided laser vision correction treatments to patients. In fact, more than 94 percent of eligible candidates in the U.S., and more than 99.75 percent outside the U.S., may potentially benefit from the Advanced CustomVue procedure.*

Benefits

• Delivers benefits of Iris Registration (IR).
• Conserves tissue by optimizing treatment times and minimizing thermal effects on the cornea.
• Minimizes additional time for wavefront-guided custom treatment over conventional treatment.
• Eliminates the need for dilation; laser tracks on the natural pupil.
• Maximizes practice efficiency and workflow through ease of use and ergonomics.
• Adjusts for intra-patient (XYZ) movement with ActiveTrak™ to further improve treatment accuracy.

*Market Scope 2005

Iris Registration™

Registration + Resolution

AMO offers the first treatment with FDA-approved automated Iris Registration (IR), a non-contact method for aligning and registering the Advanced CustomVue™ procedure. IR correctly centers and aligns the treatment, independently of pupil center migration, as well as compensates for cyclotorsional movement, providing a more precise ablation placement. With IR, you can instantly re-register treatment when necessary. By enabling much more accurate alignment, IR gives you the confidence that the treatment you deliver will be safe, effective and accurate.

Additional Benefits

• Reduces the impact of pupil centroid shift.
• Compensates for cyclotorsional movement.
• Eliminates the time needed for manual marking.
• Accommodates all wavefront guided laser vision correction procedures.
• Leverages multiple matching reference points for each iris.

From the WaveScan™ System to the STAR S4 IR™ Laser

Optimal results require precise alignment of the laser treatment. By linking diagnostic wavefront information with the treatment itself during the Advanced CustomVue procedure, IR provides a much higher level of alignment accuracy and precision, giving the surgeon confidence that the treatment will be placed in the correct location.

Optimal Outcomes with Iris Registration (IR)

A patient's pupil center will move relative to the outer iris boundary in different environments. To minimize the impact of this movement, IR:

• Records the outer iris boundary at the WaveScan and laser.
• References the WaveScan pupil center to the outer iris boundary.
• Records the pupil center relative to the outer iris boundary and compares it under the laser to the WaveScan reading.
• Centers the laser ablation over the WaveScan pupil center.

VSS/VRR

VSS and VRR: Safety and Speed

The STAR S4 IR™ Excimer Laser System features Variable Spot Scanning (VSS Refractive™) and Variable Repetition Rate (VRR™) pulse-packing algorithm, both proprietary to AMO. VSS Refractive™ produces variable beam sizes from as small as 0.65 mm up to 6.5 mm, while VRR™ varies the laser's repetition rate from 6 Hz to 20 Hz. By continually changing the size and placement of the laser beam, the STAR S4 IR™ Excimer Laser rapidly delivers the precise ablation pattern required, significantly reducing ablation time. This capability minimizes thermal effects on the cornea and allows you to perform the procedure as quickly as possible.

Additional Benefits

• Optimizes laser spot size, placement and repetition rate based on pulse-packing algorithm.
• Enables wide range of beam sizes for more precise shapes.
• Reduces thermal effects on the cornea, allowing the fastest and safest treatment speed.

Eye Tracking

ActiveTrak™ 3-D Active Eye Tracking

ActiveTrak™ 3-D Active Eye Tracking with automatic centering is the first FDA-approved tracker in the industry to track eye movements along the X, Y and Z axes. These features facilitate the accurate performance of the Advanced CustomVue™ procedure.

The VISX Star S4 IR™ Excimer Laser System is the used for the majority of laser vision procedures in North America.