Disclosures Over the past year, Matt Kauffman has received. Industry Updates. Fitting Contact Lenses in the Contemporary World

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1 Fitting Contact Lenses in the Contemporary World Maria K. Walker, OD, MS, FAAO, FSLS Matthew J. Kauffman, OD, FAAO, FSLS February 20, 2016 Disclosures Over the past year, Matt Kauffman has received research funding and/or travel from the following companies: Visionary Optics Over the past year, Maria K. Walker has received research funding and/or travel from the following companies: Ocular Dynamics Contamac Cooper Vision Contact Lens Types in 2015 Industry Updates Rigid Lens Fitting Trends 2015 Industry Trends in

2 Industry Updates from 2015 Valeant Pharmaceuticals Timeline Summer, 2015: Purchase of Paragon Vision Sciences which, with B + L, provides a virtual monopoly of corneal reshaping designs September, 2015: Valeant announces first price increase of their materials to laboratories which was particularly notable with scleral and orthokeratology designs September, 2015: Valeant Vice President Joe Sicari sends a letter to CLMA member laboratories indicating that Valeant is withdrawing from the CLMA Courtesy of Ed Bennett Valeant Pharmaceuticals Timeline October, 2015: Laboratories are notified by Valeant of a second material fee increase October, 2015: Paragon CRT partner laboratories were notified that they will no longer be a distributor after Dec., 31 (they were later sent a letter that allowed them to have a 6 month extension if desired) October, 2015: The FTC sends a voluntary request letter to Valeant Pharmaceuticals as it pertains to their acquisition of Paragon and possible monopoly considerations Valeant Pharmaceuticals Timeline December, 2015: It is reported that Valeant is considering selling Paragon Vision Sciences December, 2015: CLMA introduces a GP Comparison Chart to show CLMA member materials comparable in Dk to Valeant December, 2015: Tru-Form Optics files a class action law suit again Valeant Pharmaceuticals, in part, to restore competitive market conditions Courtesy of Ed Bennett Courtesy of Ed Bennett Industry Trends Soft Contact Lenses Practice Trends SCL 40.9 million CL wearers in U.S. Soft CL (SCL) market steadily growing 2015 worldwide market = $7.4 billion Worldwide market shares (B+L, CooperVision, Johnson & Johnson, Alcon) 2

3 Practice Trends SCL Practice Trends SCL Practice Trends Myopia Control Practice Trends Lens Care What the Future Holds Myopia control Scleral lenses Monitor blood sugar levels Change focus Expansion of current design parameters FITTING THE IRREGULAR CORNEA 3

4 What causes an irregular cornea? Irregular astigmatism principle meridians are NOT perpendicular Keratoconus Conditions: Keratoconus Pellucid Marginal Degeneration Surgical Trauma Nipple Cone Oval Cone Globus Cone Pellucid marginal degeneration 4

5 Corneal transplants Lasik Radial keratotomy Cornea cross-linking Intacs Post Surgical Post Surgical ConventionalGP Scleral lens Specialty GP Surgical design CONTACT LENS Piggy-back Intralimbal Soft CL Hybrid Contact Lens Toolbox Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses Corneal (small diameter) GPs Three fitting philosophies Apical bearing Apical clearance Three-point touch 5

6 Apical Bearing Apical Clearance Three-Point Touch Which small diameter lens to pick? How small is a small diameter GP lens? Overall diameter: 8.0 to 9.8 mm Designs Conventional Spherical optic zone Aspheric optic zone Spherical optic zone/aspheric periphery Conventional lens design Best utilized for mild keratoconus Base curve selection Peripheral curve design Spherical optic zone Steep base curve radii lenses Spherical peripheral curves Examples Soper Cone McGuire lens Rose K and Rose K2 (Blanchard) Comfort Zone design (ABBA Optical) Dyna Z Cone design (Lens Dynamics) CLEK design (Conforma) 6

7 Aspheric optic zone Can provide better fit Increased success Progressive aspheric Provide better alignment with ectatic cornea Review of eccentricity (e) Normal cornea: e=0.45 Aspheric optic zone Examples ABBA-Kone design ABBA Optical AKS (Art Optical) Apex Aspheric Cone design (X-Cel Contacts) Conforma-K design (Conforma) Spherical optic zone/aspheric periphery Spherical optic zone Aspheric periphery ( A value) Examples ComfortKone (Metro Optics) Contact Lens Toolbox Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses Intralimbal Definition: 10.0 to 12.8 mm diameter Design Conventional periphery Reverse geometry design (oblate or post-surgical) Advantages Centers better More comfortable Large optic zone Intralimbal Examples Dyna Z Intralimbal (Lens Dynamics) Rose K2 IC (Blanchard) G.B.L. lens (ABB Concise) 7

8 Advanced intralimbal options Contact Lens Toolbox Quadrant-specific design Asymmetric Corneal Technology Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses Diagram courtesy of Al Vaske: Lens Dynamics Soft CL for Irregular Corneas Spherical and toric Very mild forms Custom lathe-cut soft lens designs Aberration-control optics Best candidates Nipple and globus-type cones Concentric 360-degree peripheral topography Soft CL for Irregular Corneas Examples KeraSoft (Bausch + Lomb) NovaKone (Alden Optical) HydroKone (Visionary Optics) Contact Lens Toolbox Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses Piggy-back Rigid lens fit over top of soft lens Integrate rigid lens into soft carrier lens Candidates People who cannot tolerate rigid lens Poor lens-to-cornea fitting relationship Traditional piggy-back SiHi lens Low power (+ or 0.50 D) High power (+6.00 D) 8

9 Lens movement Power calculation Soft CL power = 20 25% of labeled power E.g D SCL = effective power 0.65 D Countersunk piggyback Flexlens (X-Cel Contacts/Walman Optical) Pillow Lens (Fusion Technologies) Piggy-back Contact Lens Toolbox Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses Hybrid lenses Rigid center Soft periphery Advantages over piggy-back Ease of care Less handling Improved comfort Hybrid lenses Examples Saturn II (Precision-Cosmet) SofPerm (Sola/Barnes-Hind, Inc.) SynergEyes Lens (SynergEyes, Inc.) SynergEyes KC (SynergEyes, Inc.) ClearKone (SynergEyes, Inc.) Duette (SynergEyes, Inc.) UltraHealth (SynergEyes, Inc.) Contact Lens Toolbox Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses CL Fitting of the Post Surgical Cornea Irregular astigmatism Post Corneal Transplant Post Radial Keratectomy Post LASIK/PRK Post Intacs Corneal Scarring Ocular surface protection Post surgical ocular surface disease (OSD) 9

10 Contact Lenses for PK 60% require contact lenses Irregular astigmatism Central corneal flattening Contact Lenses for PK Soft CL Usually milder cases of refractive error Corneal GP lenses Hybrid lenses Scleral contact lenses Post Surgical Contact Lenses Soft CL Usually milder cases of refractive error Corneal GP lenses Hybrid lenses Scleral contact lenses Custom Soft Contact Lenses When the off-the-rack won t cut it SpecialEyes Custom parameter SCL mm dia; BC Pwr: +/-25D (0.1mm increments); -8Dcyl; any axis Optic zone mm Alden Optical Alden 49, 59 (water content) Any available diameter and BC Pwr: +/-30D sphere; -10D cyl; any axis Custom Soft Contact Lenses Coopervision Hydrasoft custom 8.3, 8.6 BC in 14.2 dia 8.3,8.6,8.9,9.2 BC in 15.0 dia +10 to -30D; up to -10 cyl Art Optical Intelliwave toric Multi-aspheric front surface Wavefront technology Post Surgical Contact Lenses Soft CL Usually milder cases of refractive error Corneal GP lenses Hybrid lenses Scleral contact lenses 10

11 Penetrating Keratoplasty (PKP) Oblate Cornea post-pk Graft/Host (G/H) Interface mm Fitting Goal: Avoid interaction with G/H Interface Corneal GP lenses: Post PK Diameter: mm VAULT over graft Reverse Geometry Not always necessary Piggyback caution with Dk Lenses available: Metro Optics: RSa, RSb Comfort XL: 11.0mm, 9.0mm OZ (Valley Contax, Oregon) epostgraft: 10.5mm, 9.0mm OZ (Essilor, TX/GA/CO/OK/FL) RSS: mm (Blanchard, NH) Others available Radial Keratotomy (RK) Complications Over correction Under correction Irregular astigmatism Fluctuating vision Topography Features Central 3-5mm flattening Paracentral knee Steep periphery Post Surgical Contact Lenses Soft CL Usually milder cases of refractive error Corneal GP lenses Hybrid lenses Scleral contact lenses Synergeyes Ultrahealth: High Dk (84 SiHy skirt; 130 GP center **Ultrahealth FC (flat cornea) now available** 11

12 Synergeyes: Ultrahealth Ideal fit Contact Lenses for PK Soft CL Usually milder cases of refractive error Corneal GP lenses Hybrid lenses Scleral contact lenses Modern Scleral Contact Lenses ScCL Fitting Goals in Post-Surgical Eyes - Avoid interacting with incision sites - Consider corneal hypoxia - Compromised endothelium after surgery Contact Lens Toolbox BREAK! Corneal (small diameter) GPs Intralimbal Soft CL Piggy-back Hybrid lenses Surgical Scleral lenses 12

13 What is a scleral lens? Classification Previous A gas permeable lens which vaults the cornea and lands on the sclera Corneal Lens Diameter 8.0 mm 12.9 mm Corneo-scleral mm Semi-scleral Mini-scleral Scleral mm mm mm Sindt, CW. Basic scleral lens fitting and design. CL Spectrum 2008; Classification Revised Indications Corneal Corneoscleral Scleral Scleral Lens Education Society. June 2013 Description Mini-scleral Lens diameter < 6 mm than HVID Large scleral Lens diameter > 6 mm than HVID Bearing Area Lens rests on cornea Lens rests in part on cornea and in part of sclera Lens rests completely on sclera Vision Improvement Myopia, hyperopia, corneal astigmatism, presbyopia Irregular Astigmatism Keratoconus, pellucid marginal degeneration, post penetrating-keratoplasty Corneal Protection Ocular surface disease: dry eye syndrome, graft vs. host disease, recurrent epithelial erosions, Stevens- Johnson syndrome Cosmetics/Sports Challenges Lens insertion Handling Insertion and removal more difficult Apprehension with new lens/technique Fitting Learn to fit different part of eye Increased chair time initially Expense Fitting and materials more expensive Increase in medically necessary claims Target for insurance companies (AUDITS!) Video 13

14 Removing the lens How much do scleral lenses settle? Video What s the ideal clearance? What s the ideal clearance? 14

15 No! Is an OCT required for scleral lens fitting? OCT 541 µm 182 µm OCT Future of Scleral Lens Imaging 438 µm 157 µm Mapping the Sclera smap3d (Precision Ocular Metrology, LLC) Eye Surface Profiler (Eaglet-Eye) Scleral Lens Complications 15

16 Scleral Contact Lens Complications Non-wetting/front surface debris Epithelial breakdown Conjunctival Prolapse / Chalasis / Hooding Chamber Debris (Fogging) Corneal Edema in susceptible patients Scleral lens discomfort - Uneven scleral bearing - Excessive edge lift - Lid wiper epitheliopathy Application Considerations Dexterity (Parkinsons/tremors) Eyelid apertures Visual Status The SeeGreen Lens Inserter Application Bubble Preservative Toxicity Surface Non-Wetting/Debris Non-Wetting/Deposit buildup 16

17 Surface Non-Wetting/Deposits Apical Clearance 100um 200um 400um Apical Bearing Limbal Clearance Appropriate Limbal Clearance Too much Inadequate Limbal Clearance Scleral Bearing Impingement Blanching Epithelial breakdown 17

18 Uneven Scleral Bearing Epithelial Bogging Epithelial Bogging Giant Papillary Conjunctivitis 1 week post-fitting 2 months post-fitting Inflammatory Response Conjunctival Prolapse Prolapse Allergic response remove allergen consider steroid pulse Material / Solution Sensitivity Change accordingly Recessed Prolapse 18

19 Axial Map Elevation Map Midday Fogging Baseline OCT 4h post application Conjunctival Prolapse 8h post application Change fitting relationship to equalize clearance Managing the Fog Alter lens design to decrease excess clearance Managing the Fog Alter lens design to decrease excess clearance Managing the Fog High viscosity application solution Additional Unknown Complications Epithelial and Endothelial long-term Health Long term effects of Conjunctival Compression Long term Limbal Health Implications?? 19

20 Myopia Control Myopia Control Theory Myopia control: creating peripheral myopic defocus (more plus power). Dr. Earl Smith III Myopia Control Theory Myopia Control with Contact Lenses In OK The distant optical zone is only 2-3 mm in diameter Standard 5-Curve Design The amount of plus power in the periphery equals the amount of minus power corrected How Hyperopic is the Peripheral Retina at 30 Degrees??? D., D., D. or D. 5.0 mm D D D. Courtesy of Patrick Caroline 20

21 Five Year Axial Length Change From Baseline (mm) 2/8/2016 Peripheral Refraction with Varying Myopia The Journal of Optometry 2009 Ravi Bakaraju, Klaus Ehrmann, Eric Papas, Arthur Ho Vision Cooperative Research Center, Sydney Australia Traditional 4-5 Curve Design 165 Chinese Canadian Children D D. Average difference between the foval refraction and that 30 degrees away was between D D. and D. 5um 76 um Unpublished data from Dr. Eddie Chow Traditional 5 Curve OK Lens Design N = 165 Image Shell Myopic Asian Children Other Myopic Children Baseline Spherical Equivalent (D Rounded) Unpublished data from Dr. Eddie Chow D D D D Myopia Control 6 Curve Design 129 Chinese Canadian Children D D. 10 um 106 um Unpublished data from Dr. Eddie Chow 21

22 Five Year Axial Length Change From Baseline (mm) Five Year Axial Length Change From Baseline (mm) 2/8/2016 Base curve 5 - Curve Peripheral curve Reverse curve Secondary curve Intermediate curve Myopia Control 6 Curve Design 6 - Curve Base curve Reverse curve Intermediate curve Secondary curve Peripheral curve 6 - Curve Steeper reverse curve, more fluid in periphery Base curve Reverse curve Intermediate curve Secondary curve Peripheral curve Allows for greater epithelial cell movement into the peripheral annulus More plus power in the periphery Need 6 th curve to allow for quick flattening toward the periphery Chow Study 5 Year Axial Length Data Aspheric 6 Curve OK Lens Design N = Myopic Children Asian and Non-Asian Children Asian Emmetropic Children Non-Asian Emmertopic Children Lens Design and Myopia Control Baseline Spherical Equivalent (D Rounded) Baseline Spherical Equivalent (D Rounded) Soft Contact Lenses in Myopia Control CooperVision Biofinity Distance lens Summary of Myopia Control: Ortho K In a standard ortho-k design, the amount of peripheral defocus is equal and opposite to the amount of corrected myopia At least 5 diopters of peripheral defocus seems to be needed in order to have a myopia controlling effect Sixth curve needed in order to create greater amount of peripheral steepening, and still allow lens to flatten out appropriately in the periphery 22

23 Summary of Myopia Control: Soft CL Only commercially available SCL is CooperVision Biofinity Distance lens 2.2mm central distance zone Not FDA indicated Several custom designs available from specialty lens manufacturers Multi-center clinical trials currently ongoing to evaluate efficacy of modality RESOURCES AND PROGRAMS GP Case Grand Rounds Troubleshooting Guide Answers Practitioner s Questions Online Guide of 52 Case Studies Spherical Toric Multifocal Irregular Cornea Corneal Reshaping 23

24 Thank you! QUESTIONS? Dr. Walker: Dr. Kauffman: 24