Not Your Grandfather s Cataract Surgery-Cataract Surgery for 2015 and Beyond Jim Owen, OD, MBA, FAAO David I Geffen, OD, FAAO Cataract Surgery Eye Care Still the most common eye surgery performed Aging population makes it even more common Everyone will eventually need it if they live long enough Reimbursement continues to decline The new cataract surgery Cataract surgery IS refractive surgery Goal is a specific refractive outcome Excellent uncorrected distance Reduced dependence on glasses Multifocality Astigmatism correction IOL14052SK It s all about improving vision 1
Patients with Cataracts: What Makes Them Decide to Have Surgery? The top three reasons patients chose to have cataract surgery were: to better enjoy daily activities (75%), to improve distance visual acuity (61%), to improve blurry, fuzzy, and foggy vision (60%). 4 Current Manual Cataract Surgery Multiple steps and multiple devices Terms Technical Incision Capsulorhexis Lens Fragmentation Aspiration Lens insertion Patient Entering the eye Opening the lens Breaking up the lens Removing the lens parts Putting new window in the eye 2
Incision Entering the eye More precise with femto Better seal with femto Less likely to get infection Capulorhexsis Opening the lens Perfect circle with femto Positions the lens in the eye better Potential for better vision Lens Fragmentation Breaking up the lens Less energy with femto Less inflammation with femto Faster recovery 3
Free Floating Capsulotomies The Need for Improvement LSX12241SK Adapted from FDA Clinical Data: Crystalens* and WaveLight Trials *Trademarks are property of their respective owners. 5 Improved Refractive Cataract Surgery IOL Position Predictability Uniform Shape and Size Capsulotomy Corneal Astigmatism Reproducible Corneal Entry and Arcuate Incisions Early Wow Factor Reduced Phaco Power and Corneal Edema Norrby SJ, J Cataract Refract Surg 2008;34:368 376 Hill WJ, J Cataract Refract Surg 2008;34:364 367 Devgan U, Current Opinions in Ophthalmology 2011;18:19 22. LSX12241SK 7 4
Current Systems LENSAR Optimedica Technolas LenSx Video - Quest for zero ultrasound EPT (seconds) 10 8 6 4 2 96% decrease with Catalys 500µm grid 99% overall EPT decrease 86% additional decrease with 350 µm grid 500 µm grid LOCSIII: 3.5 ± 0.8 MK 00123 Rev E 0 Manual (N=52) 500 µm grid (N=80) Conclusion: Use of 350 µm grid led to statistically significant lower EPT than 500 µm grid 350 µm grid (N=80) 350 µm grid LOCSIII: 3.7 ± 0.8 ¹Data presented at APAO 2012. Catalys data sourced from Conrad- Hengerer I, Hengerer FH, Schultz T, Dick HB. JCRS. 2012. 5
Wavefront Intrapoerative Aberrometry A New Paradigm in Calculating IOL Power and Astigmatic Correction for Cataract - Refractive Surgery ORA System : Designed to Optimize Every Cataract Procedure ORA (Optiwave Refractive Analysis) ORA s all new Optiwave technology takes intraoperative wavefront aberrometry to a new level of precision providing surgeons a higher level of confidence Copyright 2011 WaveTec VisionTM 17 Sample WaveTec Screen Shots 18 6
Ongoing Clinical Study: IOL Power 180 of 180 eyes implanted 90 WaveTec, 90 Standard Implanted 156 eyes with 1 month post-op exams to date 6 sites (7 surgeons) Prospective, Two Groups Assignment Randomized Intraoperative Aberrometer (IA) IOL power calculation Standard IOL power calculation-no IA measurement Endpoint: Compare MAVPE for each group 1 month post-op refraction 19 ORA IA IOL Power Accuracy vs. Standard % Within Formula Predicted Target Mean Absolute Value IA 0.28 ± 0.19 Prediction Error Non-WaveTec 0.38 ± 0.35 20 Ongoing Clinical Study Toric IOL 147 of 180 eyes implanted to date 90 with 1 month follow-up Prospective, randomized Test group follows intraoperative aberrometer recommendation for spherical power, cylinder power, and axis of placement Non-WaveTec Technology follows recommendations of Toric Calculator 6 sites, 7 surgeons Endpoint: Compare distribution of post-op refractive cylinder and MAVPE 21 7
WaveTec Performance Improves Toric IOL Power Outcomes Residual Cylinder Accuracy To Target Mean Post-op: WaveTec: 0.37D ± 0.40 Non-WaveTec: 0.42D ± 0.48 MAVPE: WaveTec: 0.33 ± 0.26 Non-ORA: 0.46 ± 0.41 22 WaveTec Guides Astigmatic Management By LRIs Cumulative Post-op Refractive Cylinder Based On Commercial Database Mean Pre-op Keratometric Astigmatism: 1.22 D +/- 0.75 Mean Post-op Refractive Cylinder : 0.49 D +/- 0.51 23 Reduced Enhancements Premium Cases 24 8
OR Team Sees Everything 25 Retrospective Analysis of 3D HD Visualization vs. Conventional Oculars During Cataract Surgery Method: Analyzed consecutive cases from adjacent OR for a single surgeon Routine cataract cases using two methods of visualization Visualization Method # of Eyes Unplanned Vitrectomy TrueVision 3D 293 1 (0.35%) Microscope Oculars 461 5 ( 1.09%) Unplanned Vitrectomy rate was lower in TrueVision 3D cases Abstract: Robert J. Weinstock, M.D., ASCRS 2010 Proprietary and Confidential 26 SS1 TrueVision Refractive Cataract Toolset Limbal Relaxing Incision Provides precise incision templates Accounts for surgically induced astigmatism Compensates for cyclorotation Uses customizable nomograms Uses automated vector calculations Toric IOL Alignment Provides precise rotational alignment templates Accounts for surgically induced astigmatism Compensates for cyclorotation Displays compass for angular measurements 27 9
Slide 27 SS1 Write out SIA Sara Singer, 10/31/2012
RC Toolset LRI Tool At 6 weeks post-op, 85% 0.50D SS2 Pre-op Centroid (D) 0.133 Mean Cylinder (D) 1.090 Standard Deviation (D) 0.430 % Eyes 0.50D 4% Abstract: Robert J Weinstock, M.D., ASCRS 2011 Post-op Centroid (D) 0.051 Mean Cylinder (D) 0.368 Standard Deviation (D) 0.356 % Eyes 0.50D 85% 28 Dropless Therapy Proprietary Sterile Injectable Compounded Formulations Brought to you by Imprimis Pharmaceuticals Novel Patent-Pending Formulations Imprimis Dropless therapy is the only commerciallyavailable solution for a single injection of anti-infective and anti-inflammatory prophylaxis Proprietary technology allows for the unique combination of these drugs. The resulting small, consistent particulate size enables injection through a 27-30 gauge needle or cannula. The formulations have been optimized for the isotonicity and ph most compatible with the eye. Not injectable without technolog y Superior technolog y allows for an elegant injectable suspensio n 10
Slide 28 SS2 Keep both 6 & 7? Lets see later - needs source Sara Singer, 10/31/2012
Video Advanced Technology IOL s Treat Astigmatism at the Time of Surgery The AcrySof IQ Toric IOL offers cataract surgery patients with astigmatism: Reduction of residual refractive cylinder Improved uncorrected distance visual acuity Increased spectacle-independent distance vision 11
The Next Step in Toric Technology The AcrySof IQ Toric IOL: Builds on a long line of innovation from Alcon Takes the trusted platform for precise astigmatism correction and adds the enhanced image quality of an aspheric lens Designed for a Wide Range of Astigmatic Patients Dramatically Reduces Residual Refractive Cylinder 63% of patients achieved 0.50 diopters of residual refractive cylinder 1 87% of patients achieved 1.00 diopters of residual refractive cylinder 1 1 AcrySof IQ Toric IOL Package Insert. 12
Improves Uncorrected Distance Visual Acuity 94% of patients implanted achieved uncorrecteddistance visual acuity of 20/40 or better 1 1 AcrySof IQ Toric IOL Package Insert. Presbyopic IOL s 2011 Patient Expectations What they say is I want to be able to read What they want is Accommodation 13
The Center of a Presbyope s World Forget Most Everything! The TECNIS Multifocal IOL Full diffractive surface Posterior diffractive surface Anterior wavefrontdesigned surface 14
Full Diffractive Surface=Pupil Independence Data on File. Advanced Medical Optics, Inc. 43 US Clinical Results Study Parameters: One year, multicenter, evaluatormasked comparative clinical evaluation Conducted at 13 investigational sites Enrolled: 121 bilateral multifocal and 122 bilateral monofocal subjects Bilateral results at 1 year presented for 114 multifocal subjects Subject assignment was not randomized Based on patient s choice for a multifocal or monofocal 44 US Clinical Results Uncorrected binocular distance visual acuity N=114 45 15
US Clinical Results Uncorrected binocular near visual acuity at best distance N=114 46 US Clinical Results Ability to function comfortably without glasses N=112 47 ReSTOR Apodized Diffractive Refractive Multifocal lens with a multifocal center Diffractive/Refractive Acrylic material 16
AcrySof IQ ReSTOR IOL SN6AD3 Add Power: +4.0 D Spectacle Plane: +3.2 D Range: +10.0 D to +34.0 D A Constant: 118.9 SN6AD1 Add Power: +3.0 D Spectacle Plane: +2.5 D Range: +10.0 D to +34.0 D A Constant: 118.9 49 Binocular Defocus Curve 20/20 20/25 20/32 Snellen 20/40 20/50 20/63 20/80 20/100 +1.00 +0.50 0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 Refraction (D) IQ ReSTOR IOL +3.0 D [N=117] IQ ReSTOR IOL +4.0 D [N=114] 50 Source: AcrySof IQ ReSTOR IOL Package Insert Average Near Best Distance 38 36 Centimeters (cm) 34 32 30 28 26 Uncorrected IQ ReSTOR IOL +3.0 D [N=138] IQ ReSTOR IOL +4.0 D [N=131] 51 Source: AcrySof IQ ReSTOR IOL Package Insert 17
Introducing the Crystalens AO Primary Mechanism Optic Movement UBM Relaxed Increased Pressure Constricted Secondary Mechanism Accommodative Arching 18
Summary of Wavefront Findings crystalline Lens Power Change Greater in the center Less in the peripheral Generally greater than the change in SE Aberration Increase in negative spherical aberration Increase in coma MRI Changes to the Lens Far Near Distance Near What If You Could Change The Power Of An IOL and Treat High Order Aberrations After Implantation? 19
Light Delivery Device Adding Power to the LAL Iris light light lock-in Increased power => change in radii of curvature => change in power Subtracting Power from the LAL Iris light light lock-in Decreased power => change in radii of curvature => change in power 20
Figure 1. Schematic of the positive power adjustment mechanism. A) Adjustment: selective irradiation of the central zone of the light adjustable lens (LAL) polymerizes the macromer, creating a difference in the chemical potential between the irradiated and nonirradiated regions. B) To re-establish equilibrium, the excess macromer diffuses into the irradiated region causing swelling. C) Lock-in Treatment: irradiation of the entire LAL locks the remaining macromer so that no further change of refraction is possible. 1 month post op Summary Silicone Light Adjustable IOLs Myopic, hyperopic, and astigmatic errors Custom Wavefront Platform:, Phakic IOL, Multifocal or Accommodative IOL, Injectable IOL 21
Patient Questions Are you interested in spectacle-free vision after your cataract surgery? Would you tolerate some glare/halo at night? Would you be willing to pay an addition fee out-of-pocket for this technology? Our goal is to reduce your dependence on spectacles! Informed Consent Don t pre-judge affordability Describe all options Make specific recommendation Involve family member or friend Use visual props to explain IOL and possible visual side effects Comanagement Pearls Opportunity to provide cutting edge technology Importance of your recommendation Patient education is critical! 22
Make This an Exciting Opportunity for Your Patients This is a great time to have cataract surgery as we can offer you so much more than several years ago This is your one opportunity to select your intraocular lens and LenSx procedure I will provide you with all the information that you will need As your primary care eye doctor, I will make a recommendation and help you make this once in a lifetime decision Case Report #1 Case Report #2 23
Case Report #3 Case Report #4 Questions 24