Multifocal Corneal Excimer Ablations for Presbyopia Guy M. Kezirian, MD, FACS Scottsdale, Arizona Carlos Verges, MD, PhD Barcelona, Spain AAO 2006 Las Vegas, Nevada November 14, 2006

Disclosures Presenter is has financial relationships with WaveLight AG, AMO-Visx, eyeonics Inc. Owner of SurgiVision® Consultants, Inc. and Refractive Consultant Group, Inc. Some procedures mentioned in this presentation have NOT received FDA approval

Acknowledgments Theo Seiler, MD, PhD AMO-Visx / Bruce Jackson, MD Many of the slides and concepts used in this presentation AMO-Visx / Bruce Jackson, MD

Multifocal Excimer Ablations for Presbyopia Presbyopia is the most prevalent refractive disorder without a successful treatment Current treatments include Spectacles Monovision (contacts or surgery) Multifocal excimer ablation procedures Corneal Inlays Conductive keratoplasty (CK) Presbyopic IOL’s

Multifocal Excimer Ablations for Presbyopia Attempted from early 1990’s (Ruiz) Ablated around opaque disks placed manually on the cornea Have been attempted with various ablation profiles since that time These approaches differ from monovision because they attempt to divide monocular vision (W. Maloney)

Monocular Multifocal Vision Monovision requires suppression of the image from one eye Maintains full clarity, brightness of vision from remaining eye Suppression is common in daily life Cameras, rear-view mirrors, etc. Multifocal vision requires partial suppression of image from one eye Not a physiological condition

Monocular Multifocal Vision All corneal-based multifocal treatments are pupil-size dependent Effect varies depends on ambient light, physiologic pupil size Attempt is to provide adequate near vision and retain as much distance vision as possible Visual quality is compromised at all distances

Approaches to Multifocal Ablations Central Steep Island VISX, Schwind, B&L Central Steep Annulus Nidek Decentered Steep Island Historical Asphericity, optimization Zeiss, WaveLight

Ablation Techniques For Presbyopic Correction Central Near with Peripheral for Far : Near Luis A Ruiz : Presby lasik W Bruce Jackson, ( 2001) Franco Bartoli ( 2002) Far

Sector Near Zone Ablation Techniques For Presbyopic Correction Far Anschütz, Dausch, Klein, Joly (1991) Near

Ablation Techniques For Presbyopic Correction Peripheral Near Zone with Central Distance Far Avalos , Rozakis, Agarwal (PARM- Technique, 1998) G.Tamayo (2000) Near

Ablation Techniques For Presbyopic Correction “Global Asphericity” Or “Q-Optimized” Near Far Seiler (2005)

Why Central Near? Miosis with accommodation amplifies effect Permits a prolate corneal shape Usually provides the best vision depending on overall optical system Causes negative asphericity, which also occurs during accommodation Measured as positive spherical aberration on wavefront

Wavefront Spherical Aberration in Unoperated Myopic Eyes (N = 374) Negative: 6% None: 51% Positive: 43% Data from the US FDA Study of the WaveLight Allegretto Laser

Presby-LASIK Profile Design Superimposition of a standard correction profile (in this example myopic) with a small diameter hyperopic profile in the center:

Custom Q : profile design: Superimposition of a wavefront optimized correction profile with a highly negative target Q value ( - 0.6 )

Multifocal Corneas Advantages: Disadvantages: Ability to read with less defocus at distance Preservation of better distance Snellen acuity Disadvantages: “Light Starved” Glare, haloes, loss of contrast Loss of best-corrected acuity Patient acceptance

Current Clinical Outcomes Visx WaveLight

Visx Multifocal Presbyopia Treatments Bruce Jackson et al (Canada) Central steep zone approach Done in conjunction with hyperopia treatments BILATERAL (not just for monovision) 75 eyes in 48 patients, preop spheroequivalent up to 3.5 D

Monocular Simultaneous Uncorrected Distance and Near Vision J3 or better 20/25 or better 77% of eyes achieve both 20/25 distance and J3 near or better Slide courtesy of Bruce Jackson, MD and AMO-Visx, Inc.

Questionnaire Results Spectacle Use Percent of subjects Slide courtesy of Bruce Jackson, MD and AMO-Visx, Inc.

Wavefront Aberrations Post-op WaveScan™ HOA pattern shows central myopic area Rx Correction Map (in diopters) Case Example: ID#141202 OD 6M post-op Dist UCVA: 20/25 Near UCVA: J1 ggg Slide courtesy of Bruce Jackson, MD and AMO-Visx, Inc.

WaveLight Global Asphericity Theo Seiler, MD, PhD and Tobias Koller, MD Zurich, Switzerland

refractive difference / dpt Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD difference in size of the retinal image fusion 100% 8% 6% 50% 4% 2% 0% 1 2 3 4 5 6 7 refractive difference / dpt

Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD

Asphericity Basics Prolate shape, Q < 0, slightly myopic Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD Asphericity Basics Prolate shape, Q < 0, slightly myopic

Alternative approach: central steep island (CSI) Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD PresbyLASIK and Asphericity Alternative approach: central steep island (CSI)

Central cornea has higher refractive power Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD Precondition for a corneal shape that supports near vision in a presbyopic eye Central cornea has higher refractive power compared to peripheral cornea (= prolate cornea)

PresbyLASIK and Asphericity Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD PresbyLASIK and Asphericity Optimal corneal shape (R,Q) with a 2.5mm-pupil for near objects (0.4m) and a 5mm-pupil for far objects (5m) GLOBAL OPTIMUM (R,Q) myopia of -1.5 D regarding the central cornea asphericity constant Q = -0.7 to -0.9 (hyperprolate)

PresbyLASIK and Asphericity Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD PresbyLASIK and Asphericity photoreceptor layer retina 6 mm 4 mm 2 mm pupil size -1 mm -500μm +500μm -410μm -280μm + 70μm

PresbyLASIK and Asphericity Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD Please note The global optimum shape of the cornea is not a multifocal cornea but an aspheric hyperprolate cornea It does not produce 2 foci and the brain selects the appropriate image like in bifocal IOL's The driving force is the pupil diameter that shifts the focus of the optics The procedure is recommended for ONE EYE (modified monovision concept)

PresbyLASIK clinical data Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD pilot study, n=15, non-dominant eyes preop sph -0.5 to +1.5D, cyl < 0.75D distant VA near VA low contrast VA (100cd) (100cd) (80cd) mean 0.82 0.65 (J3) 0.58 (pre 0.62) SD ± 0.15 ± 0.08 ± 0.12 (0.2) range 0.5 to 1.0 J2 to J4 0.3 to 0.8

global optimum (R,Q) for near and distant vision PresbyLASIK and Asphericity Slide courtesy of Theo Seiler MD, PhD and Tobias Koller, MD monovision -1.5D global optimum (R,Q) for near and distant vision CSI with optimal Q distance 5m near 0.4m pupil 5mm pupil 2.5mm

Conclusions Multifocal ablations are possible with today’s technology Issues over ablation shape, contour and location are largely solved Bilateral treatments seem less likely to succeed than modification of monovision with a multifocal approach Neural adaptation may be delayed compared with monovision due to intra-ocular multifocal effect rather than total eye suppression

Conclusions Procedures seem at odds with current efforts to optimize vision and improve overall wavefronts Either procedure may be appropriate in some cases but patient selection will be a challenge – Providing realistic preoperative simulations is difficult

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