Richard L. Lindstrom, MD Founder and Attending Surgeon: Minnesota Eye Consultants Adjunct Clinical Professor Emeritus: University of Minnesota: Department of Ophthalmology Associate Director: Minnesota Lions Eye Bank Board Member: University of Minnesota Foundation Visiting Professor: UC Irvine: Gavin Herbert Eye Institute Financial Disclosures Acufocus, Inc. C,I,R C C , Abbott Medical Optics, Inc. C,I,, Advanced RefractiveC,I,R Technologies Alcon Laboratories, Inc. , AqueSys Lomb, Inc. , C,I Bausch + Bio Syntrx C,I Calhoun Vision Inc, C,I Clarity Ophthalmics C,I, Clear Sight C,I, Confluence Acquisition Partners I, Inc. I, Curveright, LLCC I, CXL Ophthalmics, LLC I, EBV Partners C,I, EGG Basket Ventures C,I, C,I ELENZA, , Encore Evision Photography, C,I, Evision Medical Laser , I, Eyemaginations, Inc. C,I, ForSight, C, Forsight Vision 6, Inc. C Foresight Venture Fund #3, C,I, Fziomed I, Glaukos C,I I I, Corporation , HEAVEN Fund , Healthcare Transaction Services High Performance Optics C,I, Hoya Surgical Optics C , ISTA, C, Lensar C,I Lifeguard Health, C,I , Lumineyes, Inc. C , Minnesota Eye Consultants, P.A. C,I, C C NASA C,I –Vision for Mars Program, c Nicox, NuLens Ocular Surgery News/Slack, , Ocular Optics C,I Ocular Therapeutix, C,I, Oculeve, Inc. C, , Omega Eye Health,C,I, Omeros Corp., C OnPoint, I, Quest C,I.R C,I , Rainwater Healthcare I, Refractec , MD, Revision Optics, Revital Vision C, I,, Schroder Life Science Venture Fund C,1, I, Sight Path, C, I 3D Vision Systems C,I, Tearlabs, Inc. C,I, Tracey Technologies C,I, Transcend C,I Medical, Inc, , True Vision, *C=Consultant C,I, C I Versant Viradax , Vision Solutions Technologies C,I, *I= Investor * MD= Medical Director *R= Royalty THIS PRESENTATION MAY CONTAIN DISCUSSION OF OFF LABEL USE OF FDA APPROVED DRUGS AND/OR DEVICES “This presentation represents the speaker’s professional experience.” “Products/procedures not approved by the FDA and off label use of FDA approved products/procedures may be discussed.” Incidence and Prevalence of Presbyopia/Near Vision Dysfunction • Universal after the age of 45 • 40% of USA population • 110-120 million people • 24% myopic (>-1.00) • 26% hyperopic (>+1.00) • 50% emmetropic (+0.875 to -0.875) • 30% also have astigmatism over 1 diopter A Few Important Concepts: Accommodation: The eyes dynamic ability to focus under CNS control through a range in power of the eye as the distance to the object being observed varies. (Usually measured in diopters or an accommodative amplitude). A Few Important Concepts: Depth of Focus: The range in distance or diopters over which an individual eye or optical system can see specific target (usually 20/40 and J3) Monovision Blended Vision: A. Most popular approach to enhance near vision worldwide B. Gives highest quality of vision. C. Aspheric IOL’s or custom ablation stabilization preferred by me. D. Visual target. 1. Distance eye: Plano to -0.50 2. Near eye: -1.25 to -1.75 Multifocal Optics A. Second most popular approach to enhance near vision with corneal or lens based refractive surgery worldwide. B. Multifocal Optics can be refractive, diffractive, or a hybrid. C. Multifocal Optics can be distance dominant, near dominant, or symmetrical. AcrySof® IQ Monofocal AcrySof® IQ Toric AcrySof® IQ ReSTOR +3 TECNIS Multifocal Family of IOLs NEW NEW AT LISA TRI / Toric Add: 3.33 D / 1.66 D Optic: Aspheric trifocal/ bifocal diffractive Material: 25% hydrophilic acrylic with hydrophobic surface Filtration: UV blocker Optic body diameter: 6 mm Overall diameter: 11 mm Angulation: from +0D to +32D (0.5D steps) Toric from -10D to +24D (0.5D steps) Quellen: Herstellerangaben AT LISA TRI / Toric Trial Physiol Trifocal IOL N=40 eyes of 20 patients, 6 months follow-up Cataract surgery Alio et al, JRS 2013 TECNIS® Symfony IOL merges two complementary enabling technologies 1. Unique echelette design feature extends the range of continuous vision1 Echelette design feature Elongated Focus 2. Proprietary achromatic technology reduces chromatic aberration for enhanced contrast sensitivity1 1. TECNIS Symfony DFU TECNIS® Symfony IOL is not FDA approved for use in the US Clinically Significant Increased Range of Vision( Depth of Focus)With Reduced Halo and Glare TECNIS® Symfony IOL delivers: - Sustained mean visual acuity of 20/20 or better through 1.5 D of defocus - Full range of functional (20/40 or better) vision through 2.5 D of defocus - Halo and glare levels comparable to that of a monofocal IOL due to the lack of a distinct second focus, coupled with achromat technology Mean VA of 20/20 or better though 1.5 D of defocus 1.5 D 2.5 D VA of 20/40 or better through 2.5 D of defocus TECNIS® Symfony IOL is not FDA approved for use in the US 1. 166 Data on File_Extended Range of Vision IOL 3-Month Study Results (NZ) Multifocal LASIK • Currently there are three general methods for Multifocal LASIK (No method is FDA approved in the U.S.) VISX Aspherical Treatment Design (Center-Near) CustomVue +2.00+0.50x125 Multifocal Ablation CustomVue + Multifocal INTRACOR Post-Op Photos (same ey a) 30 min b) 1 day Intracorneal Inlays for Enhanced Near Vision Current Corneal Inlays AcuFocus KAMRA inlay reduces aperture size and increases depth of field. The inlay harnesses useful light and allows only focused rays to reach the retina through an uninterrupted pathway. Presbia Flexivue Microlens and Neoptics Icolens are multifocal optics. The outer zone on both inlays provides near vision and the central zone has a neutral power to provide distance vision. Both inlays come in a range of powers to address the progression of near vision dysfunction over time. ReVision Optics (RVO) Raindrop Near Vision Inlay increases the steepness of the cornea centrally to provide near vision. Small Aperture Inlay Depth of Focus Inlay Design 8,400 holes (5-11 μm) 3.8mm Diam 1.6mm Aperture Presbyo pia Lens cannot accommodate With Inlay Inlay 5 μm thick Made from Polyvinylidene Fluoride Inlay matches corneal (PVDF) curvature Inlay in vivo Image courtesy of Dr. Minoru Tomita Shinagawa LASIK Center RVO: Raindrop Near Vision Inlay • Stromal Cushion 100 µm • • • Design: – A 2mm hydrogel inlay – Create a multifocal cornea – Proprietary hydrogel is permeable allowing for nutrient flow through the inlay Surgical Procedure: – Implanted ~150 microns deep – Under a corneal flap Method of Action: – Central 2mm provides near vision – Results in a 2-3mm central corneal steepening – Peripheral cornea provides distance – Transition zone provides intermediate vision Patient Candidates: – Emmetropes Presbia: Flexivue Microlens Design: Disc shape bifocal inlay with refractive power Central 0.15mm hole for nutrient flow Thickness*: 15 µm Diameter: 3.2 mm Peripheral zone with refractive power: +1.5 D to +3.5 D Surgical Procedure: Implanted 280-300 microns deep Inserted into a pocket Method of Action: Central zone provides distance vision Peripheral zone provides near Peripheral corneal also provides distance vision Patient Candidates: Ametropes between -1.00D to +1.50D *Thickness varies based on power Central zone without refractive power Neoptics: Icolens Design: Disc shape bifocal inlay with refractive power Central 0.15mm hole for nutrient flow Surgical Procedure: Inserted into a pocket Inlay preloaded into an inserter Method of Action: Central zone provides distance vision Peripheral zone provides near Peripheral corneal also provides distance vision Patient Candidates: Ametropes between -1.00D to +1.50D Inlay Accommodating IOL’s A. Third most common approach to lens based refractive surgery to enhance intermediate and near vision. B. The mechanism of action of accommodating IOL’s, like normal accommodation, is multifactorial and includes increased depth of focus benefits of pseudoaccommodation and accommodation. C. Quality of vision issues are significantly less than in a multifocal IOL, but slightly greater than with an aspheric monofocal IOL. (ARMD, glaucoma, previous refractive surgery, etc are therefore less of an issue.) Built on an Innovative Platform AT-45/ AT-45SE Nov 2003 Crystalens® AO Oct 2009 AT-Five-0 Nov 2006 AT-HD July 2008 TRULIGN™ Toric IOL May 2013 o o FluidVision Lens Design 6.0 mm optic diameter 10.0 mm overall diameter Haptic height 3.0 mm RI = 1.48 The optic is suspended between the haptics Thought on the Future A. Monovision/blended vision will remain an attractive option. B. Multifocal development is maturing and growth in use will continue for several years and then plateau. (2020) C. Accommodating IOL development is less mature than multifocal, but advancing steadily and may eventually dominate. ( 2020) D. By 2020 Accommodating IOL’s or those that increase depth of focus will become more popular, but not completely replace monovision and multifocal optics. Thank you for your attention
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