The Surgical Management of Presbyopia Presbyopic IOL s 2011 B I L L T U L L O, O D Patient Expectations What they say is I want to be able to read The Center of a Presbyope s World What they want is Accommodation Forget Most Everything! What is refraction? The bending of light as it passes through materials of differing refractive indices What is diffraction? The spreading of light as it encounters an edge or step Refraction vs. Diffraction Cassin B. Dictionary of Eye Terminology Fourth Edition; Pages 88, 225. 1
MTF at 50c/mm MTF at 50c/mm 2/23/2016 The Wave Nature of Light Multifocal Lenses Require Neuro-adaptation If waves work together, they produce a stronger wave Waves cancel each other out if they are opposites Waves can also be separated into individual components called phases Visual cortex contains no pre-wired circuitry that allows it to digest information from multifocal lenses The brain requires a period of adjustment that involves suppressing near vision when gazing at distant objects and restricting distance vision when focusing up close David Cassidy, Gerald Holton, James Rutherford (2002). Understanding Physics. Pgs 382-384 Pepin SM. Neuroadaptation of presbyopia-correcting intraocular lenses, Cur Opinion in Ophthal. Jan 2008, Vol 19:1; 10-12. Neuroadaptation and Dysphotopsias Incidence of post-op dysphotopsias varies considerably whether patients are asked about them (20-77%) or are left to self report (0.2-1.5%) Incidence sharply decreases with increasing time after surgery Full diffractive surface The TECNIS Multifocal IOL Posterior diffractive surface Aslam T et al. Long-term prevalence of pseudopghakic photic phenomena. Am J Ophthalmol 2007;143:522-24. Bournas P. et al. Dysphotopsia after cataract surgery: comparison of four different intraocular lenses. Ophthalmologica 2007; 221: 378-83. Davison J. Positive and negative dysphotopsia in patients with acrylic intraocular lenses. J Cat Refract Surg 2000; 26:1346-55. Meacock W. et al. the effect of texturing the intraoculoar lens edge on postoperative glare symptoms: a randomized, prospective, double-masked study. Arch Ophthal 2002;120:1294-98. Shambhu S. et al. the effect of lens design on dysphotopsia in different acrylic IOLs. Eye 2005;19:567-70. Tester R. et al. Dysphotpsia in phakic and pseudophakic patients: incidence and relation to intraocular lens type. J Cat Refract Surg 2000;26:810-16. Anterior wavefrontdesigned surface A full range of the sharpest vision for every patient s lifestyle TECNIS MULTIFOCAL FAMILY OF IOLs Full Diffractive Surface=Pupil Independence 0.5 NEAR VISION 0.5 DISTANCE 0.4 0.3 0.2 TECNIS MIOL ReSTOR Aspheric 0.4 0.3 0.2 TECNIS MIOL ReSTOR Aspheric 0.1 0.1 A full range of outstanding vision enhanced for patients favoring near-vision activities such as reading or knitting. A full range of outstanding vision enhanced for patients favoring activities at longer reading distances such as multimedia work. A full range of outstanding vision enhanced for patients favoring intermediatevision activities such as golfing or grocery shopping. 0.0 2 3 4 5 Pupil diameter (mm) 0.0 2 3 4 5 Pupil diameter (mm) TECNIS MULTIFOCAL IOLs PP2015CT0508 11 Data on File. Advanced Medical Optics, Inc. 12 2
US Clinical Results Study Parameters: One year, multicenter, evaluator-masked 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 100 80 60 % of Patients 40 N=114 20 0 US Clinical Results Uncorrected binocular distance visual acuity 57.9 1.0 (20/20) 86 0.8 (20/25) 98.2 100 0.6 (20/32) 0.5 (20/40) 13 14 % of 60 N=114 Patients 40 US Clinical Results Uncorrected binocular near visual acuity at best distance 100 80 20 39.5 77.2 96.5 99.1 US Clinical Results Ability to function comfortably without glasses 96.4 93.8 96.4 100 80 % of 60 Patients 40 N=112 20 0 1.0 (20/20) 0.8 (20/25) 0.6 (20/32) 0.5 (20/40) 0 Near Intermediate Distance 15 16 ReSTOR Apodized Diffractive Refractive Multifocal lens with a multifocal center Diffractive/Refractive Acrylic material AcrySof IQ ReSTOR IOL +2.5 D 1 Parameter +3.0 D 1 +2.5 D +3.0 D SV25T0 Model number SN6AD1 +2.5 D +2.0 D 0.94 mm ADD power @ IOL plane ADD power @ Spectacle Plane Central ring diameter +3.0 D +2.5 D 0.86 mm 7 # steps 9 8.4 mm2 Dist: 69% Near: 18.0% Apodized Diffractive Area Energy distribution (3 mm IOL plane) 10.2 mm2 Dist: 59% Near: 25.5% -0.2µm 1. Alcon data on file Asphericity -0.1µm 3
23 2/23/2016 Defocus Curves 1,2 Patient Profiling for ReSTOR AcrySof IQ ReSTOR +2.5 D IOL Candidates Higher amount of intermediate (53cm) and distance (4m) activities Preference for range of vision but not willing to compromise sharp distance vision Desire increased spectacle independence from 53cm and beyond. AcrySof IQ ReSTOR +3.0 D IOL Candidates Balance of near, intermediate, and distance activities desiring a broad range of vision Seek true performance at all distances from multifocal capabilities Increased spectacle independence for near, intermediate, and distant activities 1. AcrySof IQ, AcrySof IQ ReSTOR +3.0 D 2. AcrySof IQ ReSTOR +2.5 Directions for use. The TRULIGN Toric IOL Clinical Results Bausch + Lomb aspheric Advanced Optics provide 100% of light, 100% of the time Excellent acuity and contrast for driving at night Minimized halos and glare Uniform power, center to edge, for predictable results Uncorrected Intermediate Vision Uncorrected Distance Vision >20/25 86.6 % 72.4 % >20/32 94.1% 86.6% >20/40 97.8% 97.8% TRULIGN Toric IOL Key Properties 5.0 mm optic body Biconvex shape Rectangular hinged haptics Approved dioptric power range from +4.00 to +33.00 D Cylinder powers 1.25, 2.00, and 2.75 D Round-to-the-right asymmetric polyimide loops o o x Primary Mechanism Optic Movement Increased Pressure Relaxed Constricted UBM 4
Summary of Wavefront Findings crystalline Lens Secondary Mechanism Accommodative Arching 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 Far MRI Changes to the Lens Corneal Inlays Near Distance Near Inlay Concept Corneal Inlays First conceived in 1949 by Dr. Jose Barraquer Primary advantages: Tissue-sparing Removable Primary design challenges: Effective optics Biocompatibility with the cornea Stable and predictable results KAMRA Raindrop Flexivue 5
Where the inlay falls within the Patient Spectrum 3.0 mm Flexivue Flexivue (3 By Presbia (Amsterdam, mm) Netherlands) 3.0 mm Diameter / 1.8 mm Central Zone 0.15 mm Central Hole 15 20 microns thick Center Ø Power Peripheral ring of + ADD (+1.50 to +3.00) Hydrogel No distance Rx LASIK Too Young for IOL LASIK IOLs Ages 20 40 Ages 40 60 Ages 60+ Near vision loss begins 31 2.0 mm InVue Raindrop (3 mm) (Formerly Flexivue Presbylens (3 and Raindrop Vue+) By Revision Optics (Lake (2mm) mm) Forest, CA) 2.0 mm Diameter SAME Refractive Index as Cornea Changes curvature of cornea (+ lens shape) Creates Multifocal Cornea (Dist, Inter, Near) Proprietary material KAMRA (3.8 mm) ICOLENS KAMRA Inlay (3 Flexivue (3 Raindrop (2 mm) mm) By AcuFocus (Irvine, mm) CA) 3.8 mm Diameter / 1.6 mm Aperture Made of Polyvinylidene Fluoride (PVDF) Small Aperture Increased Depth of Focus Femtosecond Lasers that have custom Inlay software Flexivue : Inlay Design Best achieved with specially designed pocket software Allows accurate placement of pocket location Dimensions can be customized for specific patient anatomy ifs 150 Khz Wavelight Recent release-first cases Sept 2015 Method of action Refractive lens Design Features Bifocal Yes Lens power +1.50 to +3.50 Material used Biocompatible Inlay diameter Hydrophylic polymer Yes 3.2mm Inlay thickness 15-20 microns * Implantation depth Nutrient flow process CE Mark 300 microns Through central 0.15mm hole Yes * Thickness increases with increasing refractive power Thickness * : 15 µm *Thickness varies based on power Diameter: 3.2 mm Peripheral zone with refractive power: +1.5 D to +3.5 D Central zone without refractive power 36 6
Flexivue Candidates FLEXIVUE Microlens A transparent hydrogel implant, placed 280 to 300 microns deep pocket in the cornea of the patient s non dominant eye Flexivue Microlens received CE Mark in 2009 Currently undergoing Phase 2 of clinical trial under the FDA LIKELY APPROVED 2019 Available in over 40 countries across Europe, Latin America, the Middle East, Africa and South Korea Presbyopic, aged between 40 and 65 years (ideal patient early 50 s so power swap not needed) UCDVA in Dominant Eye, or BCDVA if planning concurrent Laser correction >20/25 UVCNA < 20/50 Endothelial Cell count >2000 in the non dominant eye Minimum 480um Monovision tolerance, patients must undergo a contact lens trial Photopic Pupil >3mm Good LASIK candidate Stable refraction Clear lens Flexivue Microlens -OCT Raindrop: Inlay Design Raindrop: Inlay Design Hydrogel Inlay 2 mm Diameter 30 μm Thick 80% Water Content Same Refractive Index as the Cornea Allows for Nutrient and Oxygen Flow through the Cornea Mechanism of Action: Profocal Shape Changing Technology Design Features Method of action Corneal Reshaping Refractive lens No Lens power N/A Material used Medical grade hydrogel Biocompatible Yes Inlay diameter 2mm Inlay thickness 30 microns Implantation depth 150-180 microns Proprietary micro-porous Nutrient flow process material CE Mark Yes Likely FDA approved early 2017 Stromal Cushion 100 µm 42 7
Profocal Shape Changing Technology Features and Benefits Inlay Naturally Reshapes the Cornea, Creating a Profocal Cornea with a Smooth Transition from Near to Intermediate to Distance Ideal pre-op refraction +0.50 - +0.75 Features Benefits Clear No Cosmetic Issues Near 100% Light Transmission Hydrogel Material Safe for the Cornea 80% Water Same Refractive Index as the Cornea Allows for Nutrient & Oxygen Flow Through the Cornea 2 mm in Diameter Placed on the Constricted Pupil, it Improves Near and Intermediate Vision while Not Limiting Distance Vision Binocularly 30 μm Thick Gently Reshapes the Cornea Changing Refractive Power Giving Patients Back their Near and Intermediate Vision ASCRS 2015 Current Research 38 patients average age 51 19 Raindrop 19 monovision 3 months all 20/20 at distance 90% Raindrop 20/25 binocular near 85% Mono 20/25 binocular near (not significant) Monocular distance Raindrop 84% 20/40 Mono 50% 20/40 Weight = 100 mcg Thickness = 5 µm KAMRA Corneal Inlay 3.8 mm 1.6 mm Inlay matches corneal curvature Material = Polyvinylidene Fluoride PVDF (IOL haptics) Inlay Design How It Works 8,400 micro-perforations (5-11µ) Pseudo-random pattern Maximize nutrient flow Minimize visual symptoms The inlay works like an aperture in a camera (opening) This small opening allows only focused images in the eye Only focused light rays allowed to reach the retina Same principle used in camera lenses to increase depth-of-focus Pinhole Principle: Increased Depth of Focus 8
Well Tolerated in the Cornea Well Tolerated in the Cornea Images of implanted cornea obtained via confocal microscopy Endothelial Cells Keratocytes Corneal Nerves OCT Cornea is quiet post-op The AcuTarget HD Instrument Uncorrected Visual Acuity in the KAMRA Inlay Eye The only diagnostic tool that helps you SEE what the patient is seeing Accurately MEASURES depth-offocus, visual quality, tear film and visual axis Helps you SELECT the best treatment for a broad spectrum of patients 100% 80% 60% Change between Pre-Op and 36 Months: Mean UCNVA improved 5 lines from J8 to J2 Mean UCDVA reduction from 20/18.5 to 20/20 Mean MRSE changed from 0.02 + 0.28 D to 0.14 + 0.72 D 53% UCNVA 73% 100% 100% 91% 100% 80% 60% 59% 47% 87% 73% UCDVA 97% 99% 97% 100% 100% 92% 40% 31% 20% 13% 0% 0% 0% 0% 0% 0% J1+ J1 Pre-Op J2 J3 36 Months J5 > J5 40% 20% 0% 20/16 20/20 Pre-Op 20/25 20/32 36 Months 20/40 *N=153 at 36 months, < 6x6 group, data on file at AcuFocus Ophthalmic Assessments and the KAMRA Inlay The following ocular assessments are possible with the KAMRA inlay in situ: Fundus pho tography OCT Visual field assessment Intraocular pressure measurement Contrast sensitivity testing Goniosco py Optic Nerve and RNFL evaluation HRT Confocal Image Summary The KAMRA inlay is an effective solution for presbyopia to bridge the gap between LASIK and cataract surgery The small aperture inlay reliably extends depth of focus providing uninterrupted vision from near to far Maintains stereopsis and binocular vision, regardless of monocular implantation The effect is proven to be stable over time Design does not interfere with ocular assessments or secondary surgical procedures Images courtesy of Günther Grabner, MD SCU-123, Rev A 9
Mechanism of Action of TECNIS Symfony IOL TECNIS Symfony IOL merges 2 technologies to provide: 1 Continuous full range of vision due to the unique echelette design feature that diffracts light to extend the range of vision High-quality vision due to achromatic technology designed to reduce chromatic aberration for enhanced contrast sensitivity Contrast performance comparable to TECNIS 1-Piece Monofocal IOL 2 TECNIS Symfony IOL Novel Diffractive Technology The TECNIS Symfony IOL incorporates proprietary diffractive echelette technology to distribute light in a way that elongates the focus 1 Echelette design feature + = Achromatic technology TECNIS Symfony IOL 55 56 TECNIS Symfony IOL Achromatic Technology Proprietary Achromatic Technology Modulated transfer function (MTF) calculated for mesopic pupil sizes in clinically validated eye models 1 Diffractive optical surfaces may also be configured to reduce chromatic aberration 1 Achromatic lens surface is designed to reduce chromatic aberration 1 Green Blue Red = clear image MTF is a measure of the amount of contrast transferred by the optics in a visual system. 2 The higher the MTF value, the more contrast is transferred to the image resulting in higher contrast sensitivity. 2 1.Weeber, H.A., & Piers, P.A. (2012). Theoretical Performance of Intraocular Lenses correcting both Spherical and Chromatic Aberration. J Refr Surg, 28 (1), 48-52.; 2. Artal, P., Manzanera, S., Piers, P., & Weeber, H. (2010). Visual effect of the combined correction of spherical and longitudinal chromatic aberrations. Opt Express, 18 (2), 1637-1648. 57 58 Clinically Significant Increase in Range of Vision 1 Cahlhoun Lens TECNIS Symfony IOL showed: Sustained mean visual acuity of 20/20 through 1.5 D of defocus Increase of 1.0 D range of vision throughout the defocus curve 1 166 Data on File_Extended Range of Vision IOL 3-Month Study Results (NZ) 59 10
Adding Power to the LAL Subtracting Power from the LAL Iris light light Iris light light lock-in lock-in Increased power Decreased power => change in radii of curvature => change in power => change in radii of curvature => change in power 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 Questions?? Silicone Light Adjustable IOLs Myopic, hyperopic, and astigmatic errors Custom Wavefront Platform:, Phakic IOL, Multifocal or Accommodative IOL, Injectable IOL 11