Disclosure. Disclosure. Background. Do Believe Me. Course Objective(s) Thank You. A Survival Guide to Refractive Surgery Recommendations 12/16/2010

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1 A Myope, a Hyperope, an Astigmat and a Presbyope Walk into an Optometry Office.. Disclosure A Survival Guide to Refractive Surgery Recommendations Carl H. Spear, OD, FAAO Pensacola, Florida Consultant Director, Professional Development & Field Implementation for CIBA Vision Alabama and Florida Administrator Vision Source Research CIBA, ALCON Speaker Companies in The Eye Care Industry A-Z COPE RS Disclosure Do Not Believe Me I Have Been Paid Do Not Believe Me I Work With Companies in The Eye Care Industry Thanks ALOA Do Believe Me If I Don t Do It I Don t Talk About It Military Oklahoma Tallahassee Private Practice Industry Today Background Thank You Course Objective(s) Dr. Katie Gilbert Dr. Dustin Grubbs Dr. Neil Hook Dr. Jill Anderson Dr. Kelly Martin Dr. David Mills Dr. Barry Concool Dr. Suzanne Day Dr. Troy Bell Dr. April Gerhard Make you more comfortable and confident in educating your patients on the BEST refractive procedure FOR THEM Give you insight to a co management and refractive surgery center perspective and the subtle nuances that determine which procedure is actually done Finish on Time 1

2 The Rules This Course is Interactive I Will Call On You I Don t Know Steroids It Depends Start Together Look to your Left and Right Other I have NO idea what I am about to say Goal leave you with 3 or 4 Nuggets Not Pearls What is the most common refractive procedure in the United States? Refractive Surgery Refractive eye surgery is any eye surgery used to improve the refractive state of the eye and decrease or eliminate dependency on glasses or contact lenses. This can include various methods of surgical remodeling of the cornea or cataract surgery. Just Numbers 1.8 Million cataract surgeries last year in the US 400,000?? Laser Vision Correction Procedures By % of US population over Million Americans will need cataract surgery 2

3 Refractive Procedures (Corneal) Automated Lamellar Keratoplasty (ALK) Radial Keratotomy (RK) Conductive Keratoplasty (CK) Corneal Transplants Corneal Inlays Corneal Onlays Intacs Photorefractive keratectomy (PRK) Laser-assisted in situ keratomileusis (LASIK) Bladeless vs Microkeratome Lasek and Epi-Lasik PresbyLASIK Combination Lateral relaxing Incisions (LRI) Refractive Procedures (IOL) ACIOL PCIOL Monofocal Toric Multifocal Accommodating Light Activated Lenses Cataracts Clear Lens Exchange Phakic Implantable Collamer Lenses (ICL) AC PC MATCHGAME Refractive Procedures (Corneal) Automated Lamellar Keratoplasty (ALK) Radial Keratotomy (RK) Conductive Keratoplasty (CK) Corneal Transplants Corneal Inlays Corneal Onlays Intacs Photorefractive keratectomy (PRK) Laser-assisted in situ keratomileusis (LASIK) Bladeless, blade-free, or all-laser lasik Lasek and Epi-Lasik PresbyLASIK Combination Lateral relaxing Incisions (LRI) Automated lamellar keratoplasty (ALK): The surgeon uses an instrument called a microkeratome to cut a thin flap of the corneal tissue. The flap is lifted like a hinged door, targeted tissue is removed from the corneal stroma, again with the microkeratome, and then the flap is replaced. Radial Keratotomy (RK) 3

4 Radial Keratotomy (RK) Conductive Keratoplasty (CK) Conductive Keratoplasty (CK) CK was FDA-approved in 2002 for the temporary reduction of farsightedness, then received approval in April 2004 for the temporary improvement of near vision in people with presbyopia Conductive Keratoplasty (CK) Conductive Keratoplasty uses heat from radio frequency Hyperopia from to diopters Over 40 Healthy eyes Stable vision for at least six months Conductive Keratoplasty (CK) Conductive Keratoplasty (CK) Conductive Keratoplasty: Conductive Keratoplasty, or CK, is an alternative to typical laser surgeries for people who are over forty and have hyperopia, astigmatism, or presbyopia. Developed by Refractec, the process received FDA approval for reduction of hyperopia and in March 2004 received first and FDA approval for vision technology that improves presbyopia. 4

5 Cornea Transplants Corneal Inlays Not Elective Option Keratoconus Disease State Trauma ACI 7000 Corneal Kamra Inlay 3.8 millimeters in diameter and only 10 microns thick Not FDA-approved, clinical trials began in 2006 by AcuFocus (B&L) Pinhole effect creates greater depth-of-focus Opaque polymer called Kynar Corneal Inlays Corneal Onlays PresbyLens (VUE+) Corneal Inlay (ReVision Optics) 2-mm diameter Inlays Under Lasik Flap Works Like Multifocal CL in Non Dom eye Flexivue System 3 mm in diameter and only 20 microns thick at the edges Outside US Placed in an artificially created pocket under the epithelium Or adhesives to attach an onlay Reversible Reshape Politics? Intrastromal Corneal Ring Segments (ICRS) Intacs 1999 Placed mid periphery Combined with femtosecond laser Keratoconus British Journal of Ophthalmology. January 2010 PresbyLASIK (Multifocal LASIK, Bifocal LASIK or LASIK for Presbyopia) Multifocal LASIK (presbylasik) is an advanced type of laser vision correction surgery that changes the shape of the eye's cornea to create different power zones for seeing at varying distances Unclear when FDA approval may occur, multifocal LASIK eventually could be a new option in the United States for correcting presbyopia 5

6 PresbyLASIK PresbyLASIK In a Canadian study reported at the 2006 American Academy of Ophthalmology conference by W. Bruce Jackson, MD, 49 farsighted and presbyopic patients were involved, and 82 eyes were treated. One year after surgery, all patients were able to see 20/25 or better in the distance and at a level of "J3" (ability to read newspaper print) or better at near. In a study published in the May 2008 issue of Journal of Refractive Surgery, 44 eyes of 22 mildly farsighted patients with presbyopia were treated with a distance-center peripheral multifocal LASIK (PML) ablation. Six months after surgery, the mean binocular (both eyes) uncorrected visual acuity (UCVA) in the distance was 20/20, and the mean binocular UCVA up close was approximately 20/25. PresbyLASIK In another 2008 study published in the Journal of Refractive Surgery, Dr. Epstein found that, about two years after having monofocal distance LASIK in the dominant eye and presbylasik in the non-dominant eye, 91 percent of 103 myopic and hyperopic patients reported being completely free of eyeglasses. The average age of patients was 53, and all were wearing bifocals or reading glasses prior to the procedure. PresbyLASIK During recent clinical trials using modified monovision with PresbyLASIK, 91.3 percent of all patients no longer needed to wear eyeglasses or contact lenses. Among nearsighted (myopic) patients, 92 percent no longer needed glasses or contact lenses. Of those who were farsighted (hyperopic), 89 percent were spectacle-free. This study involved 75 patients with myopia and 28 with hyperopia; average age was 53.3 years. Standard wavefront-guided LASIK provided monocular (single vision) distance vision in the dominant eye, and presbylasik for vision at multiple distances was used to correct the nondominant eye. Results are after 1.2 years to 3.9 years of followup. Statistics apply to use of both eyes together, or binocular vision. (Reported July 2008 in Journal of Refractive Surgery.) PresbyLASIK (Multifocal LASIK, Bifocal LASIK or LASIK for Presbyopia) Currently undergoing U.S. clinical trials, the procedure has been performed in other countries for the past several years 10,000+ IntraCor IntraCor (Technolas Perfect Vision) Outside the United States Uses a femtosecond laser to create precisely placed gas bubbles, which then reshape the interior of the cornea without penetrating the outer surface less chance of infection, inflammation or other complications? 6

7 Photorefractive Keratectomy (PRK) PRK was invented in the early 1980s FDA approval of a laser for PRK was in 1995 Still great option for some patients Thin corneas Certain occupations Fear Lasik Epi-LASIK Other Procedures LASEK Laser-assisted in situ keratomileusis (LASIK) Laser-assisted in situ keratomileusis (LASIK) The Flap Microkeratome Bladeless Femtosecond Laser The word "femtosecond" refers to the units used to measure the duration of each pulse. One femtosecond is equal to one millionth of one billionth of a second, or one millionth of a nanosecond. (Yes, really.) The procedure Traditional Custom Types of Bladeless LASIK IntraLase FS-150 The first femtosecond laser approved for bladeless LASIK in the United States FDA approval in IntraLase, Inc. has introduced several new models of this laser with advanced features. Advanced Medical Optics (now Abbott Medical Optics) in 2007 acquired IntraLase, which was incorporated into the company's CustomVue excimer laser platform. This new, integrated system is marketed now as ilasik. Types of Bladeless LASIK Other bladeless laser systems Ziemer Femto LDV Ziemer Ophthalmic Systems received FDA approval in March 2008 for its portable femtosecond laser, known as the Ziemer Femto LDV. This femtosecond laser attaches to a movable arm and can be combined with any approved excimer laser system to create a flap for bladeless LASIK called zlasik 7

8 Types of Bladeless LASIK Other bladeless laser systems Technolas Perfect Vision 520 FS (20/10 Perfect Vision) FDA clearance in 2004 Can be combined with an approved excimer laser system for bladeless LASIK procedures. Zeiss VisuMax. FDA-approved in 2007 Typically is combined for bladeless LASIK with the Carl Zeiss Meditec Mel 80 excimer laser outside the United States The Mel 80 received FDA approval in Laser-assisted in situ keratomileusis (LASIK) One study found that when given the choice, 81 percent of LASIK candidates prefer all-laser LASIK over conventional LASIK with the corneal flap cut with a bladed microkeratome Cataract Refract Surg Today. 2005: BLADELESS VISX CustomVue Ladarvision Excimer Laser Platforms Wavefront guided Allegretto Wavefront optimized Custom or Wavefront vs Traditional Custom LASIK, the excimer laser is wavefrontguided, not guided by just an eyeglasses prescription It is all about Higher Order Aberrations (HOA) Quality vs Quantity Vision Is this refractive surgery? Thoughts? Can be monofocal, toric or multifocal 8

9 Landmark Ruling January 22, 2007 Surgeon Billing for Toric Correction Surgeon Billing for Toric Correction: The Medicare program allows the patient to purchase an upgrade from a conventional IOL to an astigmatism-correcting IOL and pay additional charges beyond those associated with standards cataract surgery. They might include: Refraction Corneal topography for pre-existing astigmatism Wave front aberration testing Marking the axis of astigmatism on the eye at the outset of cataract surgery Refractive keratoplasty for residual astigmatism (LRI, AK, etc) At the surgeon s discretion, these charges may be itemized or consolidated in a package. ACIOL PCIOL Monofocal Toric Accommodating Multifocal Spherical Aspherical Materials PMMA Silicone Acrylic Collamer Edge Design Square Round Design One Piece Three Piece Properties UV Absorbing Photo chromatic Thoughts? Can be monofocal, toric, accommodating or multifocal STAAR Toric IOL AcrySof Toric IOL Toric IOLs STAAR Toric IOL One Piece Foldable Silicone Non Aspheric Two Powers Astigmatism 1.5D and 2.25D 9

10 AcrySof Toric IOL One Piece Foldable Acrylic Photo chromatic (Blue Light Blocking) Aspheric or nonashpereic Three Astigmatism Powers 1.0D, 1.5D, and 2.0D More stable in bag Toric IOL Considerations Rotation/Stability Adjustments Powers Cost Design Toric Candidates >.75D Astigmatism Not interested or not a candidate for multifocal IOLs Watch for OSD Watch for irregular astigmatism Realistic Expectations Crystalens Tetraflex Accommodating IOLs Crystalens Tetraflex Accommodating IOLs Multifocal Intraocular Lenses ReSTOR ReZoom Tecnis 10

11 AcrySof IQ ReSTOR IOL ReSTOR Talking Points Designs Aspheric 2 Near Powers (SN6AD1 and SN6AD3) Apodized Diffractive region Photo Chromatic SN6AD3 Add Power: +4.0 D Spectacle Plane: +3.2 D Range: D to D A-Constant: SN6AD1 Add Power: +3.0 D Spectacle Plane: +2.5 D Range: D to D A-Constant: Technology of the AcrySof ReSTOR IOL in Human Terms Thickness of a Human Hair = 60 microns AcrySof IQ ReSTOR IOL Conclusions True performance at near, intermediate, and distance line(s) improvement in intermediate VA in favor of SN6AD1 vs SN6AD3 Best near distance approximately 7 cm (3 in) out for IQ ReSTOR IOL +3.0 D Contrast sensitivity measured between SN6AD1 and SN6AD3 demonstrated clinical equivalence No clinically relevant increase in severe visual disturbances between SN6AD1 and SN6AD3 High rate of patient satisfaction and spectacle independence Thickness of a Red Blood Cell = 7 microns Step Height at periphery of the diffractive portion of the AcrySof IQ ReSTOR IOL = 0.2 microns Full diffractive surface TECNIS Multifocal Acrylic IOL Anterior wavefrontdesigned aspheric surface Posterior diffractive surface OptiEdge Design The TECNIS Multifocal IOL The ONLY multifocal IOL that offers: Spherical aberration correction to essentially zero Better chromatic aberration reduction A pupil-independent, full-diffractive posterior surface High-quality vision in all light conditions Clear hydrophobic acrylic Not associated with glistenings Full transmission of healthy blue light 65 TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. 66 TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. 11

12 The TECNIS Multifocal IOL US Clinical Results Over 94% of patients are able to function comfortably without glasses at ALL distances Nearly 9 out of 10 patients NEVER wear glasses 94.6% patient satisfaction at 1 year 94.2% simultaneous 20/25 or better distance AND 20/32 or better near Patient Selection and Implantation TECNIS Multifocal IOL [package insert] Abbott Medical Optics Inc. 67 TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. Patient Selection No contraindications e.g., recurrent severe inflammation or uveitis Bilateral implantation Postoperative astigmatism <0.75 D Postoperative emmetropia or max. <0.75 D hyperopia Patient motivation (e.g., high diopter glasses, hyperopia, spectacle independence) Visual expectations of the patient Exclusion Criteria Macular pathologies, glaucoma with severe visual field loss Monofocal IOL already in one eye (relative exclusion) Expected astigmatism > 0.75 D Expected myopia > +/- 0.5 D (in post-op spherical equivalent) Unrealistic visual expectations Happy with reading glasses Surgical complications, such as capsulorhexis tear, capsular folds, fixation in sulcus Patient is at risk for developing PCO 73 TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. 74 TMF Speaker s Kit CT1124 9/ Abbott Medical Optics, Inc. September 2010 Alcon launches multifocal toric IOL outside the United States The company plans to file a Pre-Market Application (PMA) for the new IOL with the U.S. Food and Drug Administration in early 2012 Implantable Collamer Lenses (ICLs) Currently Available Verisyse ACIOL (AMO) Visian ICL PCIOL (STAAR) Future Veriflex IOL (AMO) Cachet IOL (ALCON) 12

13 Verisyse (AMO) Approved for use in the United States in September 2004 Myopia ranging from diopters (D) to D, with no more than 2.50 D of astigmatism Iris fixed ACIOL Researchers concluded that though both the Visian ICL and Verisyse Phakic IOL are effective for the correction of moderate and high myopia, the Visian ICL appears to produce better overall visual acuity three months after surgery. See What You ve Journal Been of Refractive Missing. Surgery. September 2009 FDA Approval December 22, 2005 Product launch April 2006 ICL Design Posterior Chamber Phakic IOL Haptics placed in sulcus - stability Optic Vault by design 500 um over the central crystalline lens Orientation marks for proper placement and alignment in injector Foldable and injectable through a 3mm incision Indication for Use STAAR Visian ICL TM is indicated for placement in the posterior chamber of the phakic eye for Correction of myopia -3.0 D to D Reduction of myopia D to D 21 to 45 years of age < 2.5D astigmatism ACD 3.0mm or greater Stable refractive history with <0.5D change for 12 months Contraindications No previous refractive surgery Progressive refractive error Corneal/Endothelial pathology Glaucoma Narrow AC angle Cataract or capsular opacification AC Depth < 3.0mm 13

14 Contraindications History of: Iritis Synechiae Pigment dispersion Pseudoexfoliation Low/abnormal endothelial cell count per age range Keratoconus Some data to support this may be an excellent alternative Patients under age 21 Invisible to patient and others Aesthetically pleasing as the lens is invisible in the eye Only the examining MD/OD will know the lens is in place Verisyse Visian ICL Peripheral Iridotomy Most common early complication is pupillary block PIs Must Be LARGE & PATENT 0.5 mm opening (at a minimum) 2 superior placed PIs, 2 to 3 clock hours apart Prevents Pupillary Block May generate complaints (discomfort) Keep mid-peripheral Cataracts in Visian ICL FDA Trial Clinically Significant (AS) Summary 7/526 (1.3%) Incidence All Had 12.75D Preop Myopia None of the 420 Cases with <12.75D Preop Myopia Had AS Cataract Cataract Incidence is 10X Greater for patients 40 years of age (3% vs 0.3%) No AS Patient Lost BSCVa After Cataract Extraction (vs Pre ICL BSCVa) 14

15 I m not only the Hair Club president, I m also a client (Hair Club for Men) Sy Sperling The Patient Has Arrived - Now What? Stretch Break and Audience Polling The Paper Work History, History, History Age Occupation Avocation Medications Expectations How Long and Why? Ozzy Osborne Check Realistic Expectations Occupation Vocation Economics Never Prejudge Always Educate The Screener The Workup The Pre Operative Period Manifest and Cyclo with BCVA Stability Different Corneal Topography Orbscan or Pentacam Slit Lamp Exam OSD, TBUT Lid Function Pathology Contacts Current Rx Pachymetry Dominant Eye Pupil Size Wave Scan (Aberrometry) DFE OCT Wetter is better Systemic Medications Ocular medications? Current Start 15

16 Case Presentations The Perfect Patient (LASIK) History 35 yof Wants LASIK ASAP History Toric CLs No Medications The Perfect Patient (LASIK) Workup Manifest OD X 006 OS X 004 Cycloplegic stable The Perfect Patient (LASIK) Concerns Time out of Contacts Pachymetry Near Vision in Future Really?? Dryness The Perfect Patient (LASIK) The Perfect Patient (LASIK) 16

17 The Perfect Patient (LASIK) The Perfect Patient (LASIK) The Perfect Patient (LASIK) The Perfect Patient (LASIK) The Perfect Patient (LASIK) The Perfect Patient (LASIK) Post-OP Day 1 20/20 each eye 20/15 OU Continues to do well some mild dryness 17

18 The Post Op Always reassure Less is better Is more between the ears than on the eyes Let them be happy Let the patient decide if it is successful or not Our biggest problem The Princess Daddy s Little Girl History 22yof Referred by doctor that normally sends their LASIK patients to New Orleans for $799 Lasik Comes to Exam with mom and dad The Princess Daddy s Little Girl The Princess Daddy s Little Girl Workup Manifest OD X /20-1 OS X /25+1 Pachymetry The Princess Daddy s Little Girl The Princess Daddy s Little Girl 18

19 The Princess Daddy s Little Girl The Princess Daddy s Little Girl The Princess Daddy s Little Girl The Princess Daddy s Little Girl The Princess Daddy s Little Girl The Princess Daddy s Little Girl What would you do? What are the issues? Thickness Patient Age Patient/Daddy s Expectations Flat K s Referring OD 19

20 The Combo Special History 54 yof PSC Cataracts OU BCVA 20/30 Currently wearing PV MF High Works as Computer IT The Combo Special Workup Manifest OD X /30 OS X /30 Left Eye Dominant PSC OS > OD Options The Combo Special The Combo Special The Combo Special The Combo Special Treatment OS first with AIOL and LRI Post Operative 1 week 20/20 uncorrected Distance J6 at near Now what on second eye 20

21 The Combo Special Treatment OD with Tecnis MF and LRI Post Operative 1 week OD 20/20 2 uncorrected Distance J2 at near Post operative 20/20 distance J 1 near and 20/30 at 3 feet uncorrected Great Results!!! NOT I wish I was a Dentist Why me? OK 46 yo male Contact lens intolerant Does not want glasses for near wants to be as glasses free as possible Great Results!!! NOT Great Results!!! NOT Bilateral ReSTOR Distance VA 20/20 Near VA 20/20 No Glare No Halos The Hyper Hyperope 62 yo female LASIK Consult Wants to be able to see at near Should have been a myope Patient Hates it cannot see computer 21

22 The Hyper Hyperope The Hyper Hyperope The Hyper Hyperope The Hyper Hyperope The Hyper Hyperope History 47 yowf Patient for 10 plus years with history of high myopia and RGP lens wear Has been saving her money kids are older and now ready for LASIK Medications 22

23 What are our initial thoughts and concerns? RGP Wearer Near Vision after surgery Pachymetry Fundus Workup BCVA 20/20 each eye Manifest OD X 016 OS X176 Pachymetry OD 538 OS 536 Thoughts? Questions? Rules of Thumb How many microns per diopter? How much in the bed? How much total corneal thickness? Time out of contacts? RGPs? K s that Last 23

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25 VA OD 20/30 OS 20/25 OU 20/25 + Happiest patient in our practice Brownies for everyone 25

26 Thank You 26