Disclosures Advances in Cataract Surgery 2014 Doug Devries, O.D. February 2014 Douglas K. Devries Consultant or Speakers Bureau for Allergan AMO Odyssey Medical Essilor B & L TearLab Nicox Akorn Premium IOL s Technology in Cataract Surgery Advances in IOL s MulO- Focal AccommodaOng IOL s Toric IOL s Technical VariaOons of Surgery RefracOve Cataract Surgery Technological GeneraOon ExpectaOon is Plano Sphere Distance and Near Desired Laser Assisted Cataract Surgery TradiOonal Cataract Surgery Capsulotomy size directly related to EffecOve Lens PosiOon Corneal incisions are manually executed and imprecise High level of phaco power can be associated with post- op complicaoons Cataract ComplicaOons PCO 10-30% CME transient 2-10% Vitreous loss 1-5% Corneal endothelial cell loss 4-10% ReOnal detachment 0.6-1.7% CME persistent 1-2% IOL MalposiOon 0.3% Need for Corneal Transplant 0.3% EndophthalmiOs 0.1% 1
Femtosecond Laser Technology LenSx: LensAR: OpOmedica: Technolas: Nidek: Femtosecond Cataract Surgery CapabiliOes Keratome Incision Paracentesis * Limbal Relaxing Incisions Anterior Capsulotomy Anterior Capsule Polishing * Nuclear SecOoning Posterior Capsulotomy * Vitreolysis * *Future applicaoon Femtosecond Cataract Surgery: FDA Approved LenSx: Capsulotomy, Incision, FragmentaOon LensAR: FragmentaOon, Capsulotomy Victus: B & L Technolas: Capsulotomy, Incisions, Fragmentaion and Lasik Flap OpOmedica pending Nidek pending Where and When to Use Pros and Cons of Femoseond Technology Premium IOL Toric MulOfocal Monofocal IOL Costs associated with technology 2
LenSx Femtosecond Laser LenSx Laser Assisted Cataract Video IntraoperaOve Wavefront aberrometry Standard and premium IOL calculaoons Monofocal.25Diopter steps MulOfocal AccommodaOng Toric 3
Current Surgery Tools Unable to Support Future Expectations ORA (Optiwave Refractive Analysis Current Percentage of Eyes Within 0.50D of Intended Vision Outcome 100% 80% 60% 40% All Cataract PaOents * 50% Current Cataract Surgery Outcomes *Represents average of studies with outcomes between 40% and 60% Copyright 2011 WaveTec Vision TM Lasik PaOents 95% ExpectaOon Based On LASIK Outcomes 20 Historical IOL power formulas have modest success, ~50% within 0.5 diopter (D) >40% of patients dissatisfied: need glasses or request secondary enhancement surgery Surgeons bear cost of post-surgery enhancement procedures, which can reduce procedure profit by up to 50% Patients paying out-of-pocket for premium lenses expect spectaclefree, LASIK-like results Surgeons need refractive measurement when it matters most intra-operatively True Aphakic RefracOve Cylinder vs Corneal Aphakic Reading Aeer Phaco Incision has been Made Measurement Combines Anterior and Posterior ContribuOons into a Single Value Measures line of sight not Apex REFRACTIVE Cylinder not Kerotometric Cylinder Makes No AssumpOons About Index Changes like the Keratometric Index Does We Just Measure It! Pseudophakic VerificaOon Pseudophakic Case Complete 4
LRI ApplicaOon ORA Post LASIK Challenge Most effecove in Pseudophakic Least effecove in phakic Titrate LRI to target 26 Standard Cases Absolute PredicOon Error Standard Toric Cases Absolute PredicOon Error 100% 80% 80% 94% 85% 98% 94% 100% 80% 86% 94% 83% 98% 90% 68% 69% 60% 50% 60% 52% 40% 39% 40% 37% 20% 20% 0% 0.25 0.5 0.75 1 0% 0.25 0.5 0.75 1 ORA PreOp Biometry ORA PreOp Biometry N=1310, Mean 0.31 ± 0.27 N=555, Mean 0.42 ± 0.34 N=174, Mean 0.29 ± 0.23 N=81, Mean 0.45 ± 0.39 Standard Toric Cases Cylinder ReducOon Standard Toric Cases Post Op Cylinder DistribuOon Pre-op Keratometric Astigmatism N=255, Mean Cyl 1.93 ± 1.05 Post-op Refractive Cylinder N=255, Mean Cyl 0.45 ± 0.49 100% 86% 93% 88% 80% 71% 60% 62% 47% 40% 20% 0% 0.25 0.5 0.75 1 ORA Alcon FDA Clinical Study N=255 N=244 5
Post Myopic LASIK Absolute PredicOon Error Post Hyperopic LASIK Absolute PredicOon Error 100% 89% 95% 99% 100% 87% 94% 80% 80% 74% 60% 55% 60% 45% 40% 40% 20% 20% 0% 0.25 0.5 0.75 1 0% 0.25 0.5 0.75 1 N=83, Mean 0.27 ± 0.22 N=31, Mean 0.39 ± 0.41 On-Demand Measurement Impacts 93% of Surgeon s IOL Decision-Making WaveTec Confirms Surgeon Choice WaveTec Calculation vs. Final IOL Power Choice Surgeon Pre-op Calc Chosen 40% 53% WaveTec Better Than Surgeon Choice Case Studies: ORA Improves Accuracy, Reduces Surgical Enhancements & Follow-up Costs Pre and Post Op Cylinder(AsOgmaOsm IdenOfied) 2.0 1.5 1.0 0.5 0.0 Without ORA: n = 37 With ORA: n = 30 PRE- OP POST- OP Surgeon Number of ORA Procedures Reduced Enhancement/ Revision Rate With ORA Prior to ORA With ORA K. Assil, MD 1,042 20% 3% E. Donnenfeld, MD 478 35% 8.5% S. Lane, MD 278 10% 5% M. Packer, MD 217 16% 3% D. Tran, MA 556 17% 6% R. Weinstock, MD 798 10% 6% W. Wiley, MD 1278 15% 3% M. Woodcock, MD 1630 10% 2.5% Average 784 17% 5% n=2212 25 sites 33 Copyright 2011 WaveTec Vision Reference: WaveTec AnalyzOR data, Jan-Nov 2011. TM Packer, IntraoperaJve Wavefront- Guided Enhancement of LRI s A RetrospecJve Study JCRS May 2010 Copyright 2011 WaveTec Vision TM Madhavi, Wavefront- Guided Custom Cataract Surgery A New Value ProposiJon for Cataract Surgeons SM2 Strategic 2011 34 ORA Increases Accuracy of Post- Surgical Outcomes Improved Premium IOL Outcomes Higher Level of Technology Increased Cost to PaOents Increased Time in O.R. Opportuni)es 78 Million Americans (babyboomers) will begin Enrolling in Medicare Beginning in 2011 Technology Adopters Care is Provided in Your PracOce Our Role to Educate and Guide 6
Aging Popula)on * Average annual increase in 60 year old or older populabon is 3.4% Growth Projection for 60+ Population 2014 Cataract Market * US cataract procedures are esomated to grow 3% annually between 2009 and 2014 Prevalence of Cataract by Age Year Age * Marketscope, The Global IOL Market, June 2009 * Marketscope, The Global IOL Market, June 2009 2009 US Market Analysis * PC- IOLs are expected to be: 7% of total IOLs implanted 15.5% of total IOL revenue IOL Market Share by Revenue 2009 US Market Analysis * PC- IOLs are expected to be: 7% of total IOLs implanted 15.5% of total IOL revenue Why isn t this IOL Market Share by Revenue percentage greater? * Marketscope, The Global IOL Market, June 2009 * Marketscope, The Global IOL Market, June 2009 Prevalence of Astigmatism Corneal Topography 35% 30%31% 30% 25% 20% 19% 1.5 D to 3.5 D = 20% Normal Cornea 15% 10% 5% 0% 10% 5% 2% 1% 1% 0% 0% 0% 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 CORNEAL CYLINDER (D) Astigmatic Cornea A corneal topography map is the most accurate way of determining and recording the STEEP meridian. 7
Effect of 1.5 D Cylinder on UCVA Limbal Relaxing Incisions Toric IOL Standard IOL Similar to AsJgmaJc Keratotomy 600 microns deep Up to 6mm in length Can be paired for larger amounts of Cyl Up to 3.00 Diopters of Cyl 8
Limbal Relaxing Incisions Less Stable and Less Predictable then Toric IOL Can Be Used In CombinaJon With Toric IOL In Higher Cylinder Amounts Non- Covered Services RefracOon Contact Lens Trial Wavefront TesOng Topography Pachymetry RouOne Care Keratoplasty for Enhancement IOL Exchange Pre- OperaJve Care Comprehensive Exam Accurate RefracOon Manual Ks Careful Cornea Eval Presence of Gupata or other Deficient Tear Syndrome BlephariOs / MGD Careful DFE Special TesOng BAT K Topography Pre- OperaJve Care Pachymetry IOL Master / A- Scan IOL CalculaOons Corneal Topography IOL Technology Wavefront AccommodaOng MulO- Focal Toric Images: GeociOes.com 9
What is 20/20? All of the following represent 20/20 vision (Spherical AberraOon) Young Lens Aging Lens Spherical IOL s Tecnis IOL Available Aspheric IOL s AMO Tecnic Alcon AcrySof B & L Aspheric LensTec 10
IOL Master Candidate for Toric IOL Careful Manifest RefracOon or Past History of RefracOon Amount and Axis of Cylinder Manual Keratometry Topography Careful Analysis Discussion of Method Discussion of ExpectaOons Candidate for Toric IOL? 72 Year Old Male PC +.50-1.75 X 083 -.25 1.25 X 088 MR +.25 1.50 X 090 -.50 1.25 X 085 Auto K s 41.87/43.25 @ 178 41.50/43.00 @169 Candidate for Toric IOL? 67 Year Old Female PC - 1.25 2.50 X 140-1.50 1.75 X 156 MR - 2.00 2.50 X 142-2.00 2.00 X 158 Auto K s 45.00/44.00 @ 160 44.75/44.00@180 11
Ideal Candidate Ideal Candidate OD Pl - 1.75 X 005 K s 44.75/43.00@006 Prior to Premium IOL AMO Tecnis Toric Rule of Anterior Segment Perform EvaluaOon for Dry Eye Disease Treat Dry Eye Disease in Advance 12
STAAR Toric IOL B & L ToricCrystalens FDA device description. The crystalens is a modified plate haptic lens with hinges across the plates adjacent to the optic. Crystalens Aspheric AcrySof Toric Plate vs HapJc RotaJon Capsule Immediate Post- Op On Axis 13
Oblique to Stria Pseudophakic VerificaOon Targeting Zero Residual Cylinder v Toric IOL is tolerant of axis deviations v 10 results in cylinder reduction of 2/3 v 20 results in cylinder reduction of 1/3 v Partial reduction with up to 30 misalignment 14
Toric Rotation IOL within 15º of intended meridian? YES No action necessary IOL ReposiJoning Ideal Time Frame 2 Weeks Capsule Fibrosis and Shrinking Creates Lock and Key Aeer 3-4 Weeks NO Consider reposition if the patient is symptomatic. OpOons Pre- Op EvaluaJon Possible ReposiOoning If soon enough Laser RefracOve Surgery Limbal Relaxing Incisions Spectacle CorrecOon Contact Lens Zonular Weakness - PXE Poor pupil dilaoon Dandruff- like flakes Phacodonesis 25% of zonules weak Capsular tears Vitreous loss Post- op inflammaoon Capsular phimosis Scandinavians up to 20% Capsular Tension Rings Stabilize lens- zonule complex CircumferenOal expansile force to capsular equator Forces equally distributed Can be lee in place Prevents capsular phimosis 15
IntraoperaJve Floppy Iris Syndrome SelecOve alpha- 1A receptor subtype blocker Rapaflo silodosin Non- subtype selecove alpha receptor blocker Hytrin terazosin Cardura doxazosin Uroxatral alfuzosin Flomax - Tamsulosin SelecOve alpha- 1A receptor subtype- blocker Treats benign prostaoc hypertrophy Loss of iris dilator smooth muscle tone- permanent Relaxes smooth muscle of bladder neck/prostate Treats urinary retenoon in women NutraceuOcal Saw palmepo Flomax - Tamsulosin SelecOve alpha- 1A receptor subtype- blocker Treats benign prostaoc hypertrophy Loss of iris dilator smooth muscle tone- permanent Relaxes smooth muscle of bladder neck/prostate Treats urinary retenoon in women IntraoperaJve Floppy Iris Syndrome Iris billowing and floppiness Iris prolapse thru incisions Progressive miosis during surgery IFIS Strategies Pre- op atropine Intracameral epinephrine Viscomydriasis Flexible iris retractors Malyugin expansion ring MulO- Focal IOL s AMO Array (first generaoon) AMO ReZoom Alcon ReSTOR Alcon Aspheric ReSTOR (yellow) Alcon ReSTOR 3.0 AMO Tecnis MulO- focal 16
Apodized DiffracOve OpOc Aspheric ReSTOR Apodized DiffracBve IOL Apodized diffracbve structure blends into peripheral refracbve region Gradually emphasizes energy going to distance vision with larger pupil sizes NighVme visual disturbances minimized by direcbng more light to distance when pupils are larger 3.6 mm 1.3 micron step 1.5 mm AcrySof ReSTOR Aspheric IOL Design The AcrySof ReSTOR Aspheric IOL model SN6AD3 is designed with negative spherical aberration. MulO- Focal IOLs PaOent SelecOon Source: SN6AD3 Package Insert RES717 Tecnis MulOfocal ReSTOR Aspheric +3.0 D IOL High- quality vision in any light condioon Near, far, and intermediate: Excellent vision day or night Proprietary non- apodized opoc and proven clear hydrophobic acrylic for best image quality 17
Crystalens Model AT- 45 Z- Syndrome / CCS FDA device descripbon. The crystalens is a modified plate hapoc lens with hinges across the plates adjacent to the opoc. Newest Crystalens HD IOL Power and AccommodaOon Axial Length (mm) 22 23 24 25 26 27 IOL Power (D) 27 24 20 17 14 11 Accommodation per 1.0 mm forward IOL movement (D) 1.9 1.6 1.3 1.1 0.9 0.8 How is AccommodaOon Achieved? 1. Ciliary muscle contracoon 2. Ciliary body shies forward 3. Pressure change in vitreous 4. Displaces posterior capsule 5. Crystalens moves forward Journal of Cataract and RefracOve Surgery. Vol. 29, #11 p. 2069-2072 ReZoom IOL PaOent SelecOon Pre- operaove ConsideraOons PaOents who no longer desire to wear glasses Ocular pathology Dry Eye Disease Dry Eye EvaluaOon Corneal scarring Injuries HerpeOc IK 18
PaOent SelecOon Pre- operaove ConsideraOons Ocular pathology OpOc nerve disease Ischemic opoc neuropathy OpOc neurios Amblyopia PaOent SelecOon Pre- operaove ConsideraOons AsOgmaOsm consideraoons Pre- op cylinder < 0.75 D ideal Cylinder 0.75 RefracOve vs Corneal??? Intra- op AK/LRI Post- op excimer Tx PaOent SelecOon Pre- operaove ConsideraOons PaOents visual demands OccupaOonal needs RealisOc expectaoons Avoid in hypercriocal paoents If RefracOve???? A Trial Frame or Spectacle CorrecOon Will Resolve Issues If Not Resolved CentraOon PCO Pathology OCT Ocular Surface Disease/MGD Possible OpOons Possible ReposiOoning If soon enough Laser RefracOve Surgery Limbal Relaxing Incisions Spectacle CorrecOon Contact Lens 19