2/18/2014 DISCLOSURE STATEMENT. Course Title:

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1 DISCLOSURE STATEMENT TLC Vision - Employee Course Title: Surgical Correction of Presbyopia Lecturers: Bill Tullo, OD, FAAO Diplomate of AAO Cornea Contact Lens & Refractive Surgery Vice President of Clinical Services TLC Laser Eye Centers Derek Van Veen, OD Regional Clinical Director South East TLC Laser Eye Centers Correction of Presbyopia The Holy Grail of Refractive Surgery Michael C. Schultz, MD (Feb 2012, Cataract and Refractive Surgery Today) Demand for surgical treatment options has increased Currently available technologies are limited Loss of contrast acuity, quality of vision Corneal Treatment of Presbyopia Monovision Conductive Keratoplasty Multifocal Corneal Ablations Central, aspheric micro-monovision Peripheral presby-lasik Intrastromal Ablations Corneal Inlays Monovision LASIK or PRK Most common target: to Near to intermediate vision in the nondominant eye Use of electronic media is growing (intermediate range more important) Near correction needed for small print, eventually Conductive Keratoplasty Radiofrequency applied to peripheral cornea Thin, hand held probe delivers khz to stroma 8 spots, 500 um deep 6, 7, or 8 mm optical zone/s For mild to moderate hyperopia For emmetropes with early presbyopia Effective monovision (about +1.00) in the non-dominant eye Radio waves shrink collagen, steepen corneal contour CK, uclaser.com sciencedirect.com Histology 1 week post CK Conductive Keratoplasty Advantages: Considered non-invasive, in office 5 minute procedure Quick recovery (24-48 hrs) Low cost, portable device Limitations: Regression common Lasts 3-5 yrs (repeatable) May induce astigmatism Less predictable than other methods healio.com; Postoperative day 1 healio.com; peripheral corneal scars from prior CK 1

2 Multifocal Corneal Ablations PresbyLASIK Multifocal Corneal Ablation with Excimer laser Nonlinear Aspheric Micro- Monovision Bull s-eye Theory Center for near vision Peripheral zone for distance PresbyLASIK - VISX Central area is hyperpositive for near vision [1] Midperipheral cornea is for far vision [1] Overall improvement in acuity at near and distance 48% of eyes achieved 20/20 uncorrected visual acuity [2] US FDA clinical trials - halted Safety and quality of vision have been compromised [2] 20% of presbylasik eyes lost 2 lines of bcva at distance 52% of eyes lost 2 lines of bcva at near vision Ophthalmologymanagement.com: Topography pattern of central PresbyLASIK 1.Dolores Ortiz, PhD, Carlos Illueca, PhD, Jorge L. Alió, MD, PhD (1 January 2008). "PresbyLASIK versus multifocal refractive IOLs". Ophthalmology Times Europe 4 (1) Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbylasik). J Refract Surg. 2006;22: PresbyLASIK - Supracor Central presbylasik technique designed by Technolas CE marked, approved for hyperopic presbyopes Not FDA approved in the US One year results (16th ESCRS winter mtg): > 90% had binocular UCVA at dist and near of 0.8 (20/25) or better Symmetrical SUPRACOR (target both eyes) is safe, effective, and stable, in the short term Asymmetrical Supracor being tested: Emmetropia for dom eye; sphere for non dom eye aimed at younger presbyopic patients Peripheral Presby-LASIK Peripheral presby-lasik in non-dominant eye Distance correction in the dominant eye Annulus Style The center 6mm is for distance The peripheral zone runs from 6-9mm for near PresbyLASIK with modified monovision; allaboutvision.com Dr. Soler s team, at Barcelona s OFTALNOVA-TEKNON clinic: INTRACOR Femtosecond intra-stromal laser for presbyopia (Ruiz, 2007) 5 consecutive rings around line of sight, 100 um deep Biomechanical steepening of cornea ~0.75 D Increases depth of focus Improves UCVA at Near Advantages: No flap, corneal integrity intact Less risk of infection Fast procedure sec of laser Fast recovery Steroid QID x 1 wk, no antibiotic Journal of Refractive Surgery Vol. 28, No. 3, 2012; INTRACOR 1-year Results/Holzer et al augenarzt-brief.deshare INTRACOR INTRACOR Central clear optical zone is mm Space anterior/posterior to incisions is 100 µm Incisions slant toward apex of cornea Length of incision increases toward center of cornea Space between incisions is 0.20 mm journalofemmetropia.orgshare: Intrastromal incisions in a cornea after Intracor 2

3 INTRACOR Study Results Study by Holtzer et al: 1 year post INTRACOR in non-dom eye 63 eyes, average age 54 y/o Preop: Mildly hyperopic (+0.50 to +1.00, up to cyl) Results: Average diopter shift in manifest postop 94.8% had > 20/40 Dist UCVA, no diff from preop 70.7% had > 20/40 or better Near UCVA post op All achieved improved Near UCVA: 1-9 lines Limitations: Loss of 2 lines distance BCVA in 7.1% Decreased vision in dim illum: 32.8% post op versus 17.2% preop Satisfaction Rate: 71.4% satisfied, 19.6% not satisfied, 9% uncertain 80.4% would recommend it, 16% would not, 3.6% uncertain Journal of Refractive Surgery Vol. 28, No. 3, 2012; INTRACOR 1-year Results/Holzeret al Mike P. Holzer, MD INTRACOR Presbyopia Cavitation gas in ring cuts Gas escaped from cornea 4 days preop 1 hour postop 1 day postop 4 days preop 1 hour postop 1 week postop Corneal Inlays Under investigation x 20 years Long-term stability dependent on: Permeability to nutrient transport Health of keratocytes anterior to implant Improved biocompatibility: Changes to material design and dimensions Reversible Corneal Inlays Strategies Bifocal or refractive lens power Flexivue; Presbia Cooperatief UA Aspheric enhanced depth of focus Vue+ Corneal Inlay, formerly PresbyLens ReVision Optics, Inc. Pinhole enhanced depth of focus KAMRA Corneal Inlay; Acufocus, Inc. Placement: Over line of sight, critical Intraoperative aberrometry The Kamra Corneal Inlay Not currently FDA approved, investigational Optical principle based on pinhole phenomenon Smaller apertures create greater depth-of-focus Allows clear vision at all distances Near, intermediate and distance The Kamra Inlay is placed : Under a LASIK flap or Inserted into a corneal pocket About 200 um deep in the central corneal stroma Image: AcuFocus 3

4 AcuFocus KAMRA How it Works A small aperture is created by the AcuFocus ACI The dark ring around the aperture blocks unfocused light on the retina Inlay Design Thickness: 5µ Weighs less than a salt crystal Curvature: 7.5 mm radius Blocks unfocused light Allows focused light into the eye 1.6mm Ø 8,400 holes (5-11µ) 3.8mm overall diameter Depth of Focus Simulation Corneal Health f/5.6 simulates human eye ~ 4.0 mm pupil f/22 Simulates the effect of the Inlay ~ 1.6 mm pupil Pseudo-random Pattern Variable Hole Size Controlled Hole Density Solid Edges KAMRA Physiology 23 The AcuFocus KAMRA Procedure Topical anesthetic eye drops O2 Flap created The AcuFocus ACI 7000 is inserted and centered cytokines Flap/Tunnel 200 micron The flap is closed Takes less than 30 minutes - start to finish H2O glucose 23 4

5 LASIK + Inlay For Presbyopia Tomita et al JCRS, 2012 LASIK OU for hyperopia, myopia then corneal inlay in non-dominant eye 360 eyes, age 52.4 (41-65 y/o) UCVA at Near, Distance improved by: 7 lines, 3 lines in hyperopic eyes 6 lines, 1 line in emmetropic eyes 2 lines, 10 lines in myopic eyes LASIK + Inlay For Presbyopia Tomita et al, 2012 Results cont. Symptoms occurred occasionally: Dry eye, glare, halo, NV disturbances Patients satisfied with decreased dependence on reading glasses Regardless of preop spherical equivalent Cosmesis Inlay may be visible in light eyes from oblique angle, when pupil is smaller than 3.8mm in the non-implanted eye 29 Patient Expectations Goal: reduce dependency on glasses 5% still use readers regularly Others may need in dim light, fine print held closely, prolonged reading Possibility of mild halo/glare, dimness Occasional recentration necessary: done early 1% removed: normal visual recovery Ideal patient: easy going, patient, cooperative Importance of compliance with dry eye regimen Under-promise and over-deliver! 30 Actual patient images courtesy of David Allamby, MD, Focus Clinics London 5

6 Does the Inlay Affect Ophthalmic Assessments? 31 Crystalline Lens 32 Cataracts and lens opacities can be easily viewed with a dilated pupil Anterior Chamber Angle 33 Fundus Exam: Center & Periphery 34 Inlay Chamber angle Gonioscopy imaging can be easily achieved Image courtesy of Günther Grabner, MD Retina evaluation and photography with the inlay in place Image courtesy of Günther Grabner, MD Macula: Stratus-OCT 6 months post-op 35 Optic Nerve Imaging 6-months post-op 36 Optic Nerve and RNFL evaluation easily achieved Images courtesy of Gunther Grabner, MD High resolution retinal imaging can be easily achieved even through a non-dilated pupil 6

7 Visual Field 37 Pentacam Printout Post-KAMRA Inlay Implantation 38 Non-KAMRA Eye KAMRA Eye Summary Over 15,000 inlays implanted to date with excellent outcomes Improvement in near and intermediate visual functionality Minimal effect on distance vision Minimal compromise in visual quality Versatile: emmetropes, ametropes, LASIK/PRK, IOLs Robust: Results maintained over the long-term Follow-up care shares features of LVC and MF implants Design allows for ocular assessments and/or secondary surgical procedures The Best Presbyopic Surgical Option to Date 39 Intraocular Treatment of Presbyopia Multifocal IOLs Refractive ReZoom (AMO) Diffractive ReSTOR (Alcon) TECNIS (AMO) Accommodative IOLs Crystalens (B & L) Refractive vs. Diffractive MF IOLs Refractive Zones vs. Diffractive Steps Refraction: The bending of light as it passes through materials of different refractive indices Diffraction: The spreading of light as it encounters an edge or step Refractive multifocals often use alternating zones Zones work independently Each zone creates one focal point Diffractive multifocals use series of steps (gratings) Steps work together Each step creates multiple focal points d n d n d Cassin B. Dictionary of Eye Terminology Fourth Edition; Pages 88, 225. Fine I, et al. Refractive Lens Surgery Pgs

8 ReZoom MF IOL Refractive MF IOL by AMO An improved version of the Array IOL Hydrophobic acrylic material Three-piece design with PMMA haptics 6.0 mm optic, 13 mm overall length Power Range: D Known for good intermediate vision ReZoom MF IOL Balanced View Optics Technology Distance-Dominant Zone 5 (Low Light) Distance-Dominant Zone 3 (Mod-Low Light) Distance-Dominant Zone 1 (Bright Light) Near-Dominant Zone 4 (Low Light) Near-Dominant Zone 2 (Mod-Low Light) Aspheric Transition (intermediate vision at all zones) Diffractive Multifocal IOLs Anatomy of Apodized Diffractive Technology Non-Apodized Full Optic Diffractive Pupil Independent Balanced for near and far regardless of light conditions Quality near image in low light Apodized Diffractive Hybrid Pupil Dependent Distance dominant in low light Reduced functionality at near in low light TECNIS Multifocal IOL Anterior aspheric optic Central 3.6 mm apodized diffractive structure Step heights decrease peripherally from microns (apodized) A +4.0 add at lens plane equaling +3.2 at spectacle plane Outer refractive zone (bends light) Fine I, et al. Refractive Lens Surgery Pgs AcrySof ReSTOR IOL Pupil Size & Diffractive Optics Pupil Size & Diffractive Optics 0.5 DISTANCE VISION 0.5 NEAR VISION MTF at 50c/mm Full Optic Apodized Hybrid MTF at 50c/mm Full Optic Apodized Hybrid Pupil diameter (mm) Pupil diameter (mm) Data on File. Advanced Medical Optics, Inc. Data on File. Advanced Medical Optics, Inc. 8

9 Refractive monofo onofocal 1st Diffra stgeneration iffractiv tive zonal refra r efractiv tivefar focus Optical Principles of IOLs near focus far focus near focus far focus Intermediate Vision with Diffractive Lenses Overlapping energy from near, distance foci create intermediate image Intermediate may be improved by Reducing add power (decreases magnification of near image) Enlarging central zone Near Point Distance Point Energy for Distance Energy for Near Intermediate 2/18/2014 Neuro-Adaptation MF IOLs require neuro-adaptation Visual cortex contains no pre-wired circuitry to digest information from multifocal lenses The brain requires a period of adjustment: Suppressing near vision when gazing at distant objects Restricting distance vision when focusing at near Pepin SM. Neuroadaptationof presbyopia-correcting intraocular lenses, Cur Opinion in Ophthal. Jan 2008, Vol 19:1; Neuroadaptation and Dysphotopsias Incidence of post-op dysphotopsias vary If patients are asked about them = 20%-77% When self reported = 0.2%-1.5% Incidence sharply decreases with increasing time after surgery (neuro-adaptation) Aslam T et al. Long-term prevalence of pseudopghakicphotic phenomena. Am J Ophthalmol2007;143: BournasP. et al. Dysphotopsiaafter cataract surgery: comparison of four different intraocular lenses. Ophthalmologica2007; 221: Davison J. Positive and negative dysphotopsiain patients with acrylic intraocular lenses. J Cat Refract Surg2000; 26: 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: ShambhuS. et al. the effect of lens design on dysphotopsiain different acrylic IOLs. Eye 2005;19: Tester R. et al. Dysphotpsiain phakicand pseudophakicpatients: incidence and relation to intraocular lens type. J Cat Refract Surg2000;26: Alcon ReSTOR AcrySof IQ ReSTOR MF IOL 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:

10 AcrySof ReSTOR Aspheric IOL Design Designed with negative Spherical Aberration Negative SA in lens compensates for positive SA of the cornea SA is when light rays are overrefracted at periphery of a lens system Regional defocused light decreases image quality Aspheric optics align light rays, compensate for + SA of cornea and enhance image quality Source: SN6AD3 Package Insert 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Overall Frequency of Spectacle Wear (Bilateral comparison) Source: AcrySof IQ ReSTOR IOL Package Insert IQ ReSTOR IOL +3.0 D [N=138] IQ ReSTOR IOL +4.0 D [N=131] Never Sometimes Always How often do you wear eyeglasses? Visual Disturbances Mean Impact Ratings 3 months postop (following second eye implant) Over 95% of ReSTOR IOL +3.0 D Patients Would Have the Same Implant Again None Mild Moderate Severe Problems with Night Vision Problems with Color Perception Halos Glare/Flare Double Vision Distorted Near Vision Distorted Far Vision Blurred Near Vision Blurred Far Vision None/Mild = 0 to 2 IQ ReSTOR IOL +3.0 D [N=138] IQ ReSTOR IOL +4.0 D [N=131] Moderate = 3 to 5 Severe = 6 to 7 Source: AcrySof IQ ReSTOR IOL Package Insert Percent of Subjects 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% IQ ReSTOR IOL +3.0 D [N=138] IQ ReSTOR IOL +4.0 D [N=131] No Yes Would you have the same implant again? Source: AcrySof IQ ReSTOR IOL Package Insert Better Intermediate and Distance Vision and Increased Spectacle Independence Tecnis Aspheric Diffractive MF IOL Measure ReSTOR /ReSTOR Akaishi & Fabri (Brasil; ASCRS 2006) ReZoom /ReZoom TECNIS MF /ReZoom ReZoom /ReSTOR Patients Near J 1.40 J 2.30 J 1.30 J 1.50 Intermediate J 3.85 J 2.15 J 2.30 J 2.30 Distance 20/25 20/20 20/20 20/20 Reading Speed Spectacle Indep. Clinical data courtesy of Akaishi, MD and Fabri, MD 165 wpm 125 wpm 180 wpm 155 wpm 89% 75% 100% 100% Multifocal lens with a multifocal center Single zone optic Silicone material 10

11 Why Target Zero Spherical Aberration? Wavefront aberration analysis confirms the average human cornea has microns of spherical aberration throughout life 1 Studies show peak visual performance occurs at 19, when average spherical aberration is 0.0 microns 2 Chromatic Aberration Correction What is chromatic aberration? Occurs when light is separated into its spectral components and these wavelengths are refracted differently to create multiple focal points 1 Holladay JT, et al. J Refract Surg. 2002;18: Artal P, et al. Presented at ESCRS Holzer M. Data presented at the DOC in Nuremburg, Germany, Spherical and Chromatic Aberration Several studies have shown the correction of spherical and chromatic aberration together is more beneficial than the sum of the two individual corrections* This is a major distinguishing factor for the new TECNIS Multifocal Acrylic IOL High Spectacle Independence with TECNIS Patient Satisfaction Study indicates (n=59 eyes out of 30 patients)* Near Vision Without Correction Monocular Uncorrected Distance 90% at J1 90% at 20/30 Spectacle Independence 93-95% Patient Satisfaction 96% *Yoon GY, Williams DR. J Opt Soc Am A Opt Image Sci Vis. 2002;19: Manzanera S, et al. Ophthalmol Vis Sci. 2007;48:E-Abstract *Refractive lens exchange with the diffractive multifocal TECNIS ZM900 intraocular lens. Goes F. J Refract Surg ;24(3): Toygar B. Patients highly satisfied with bilateral diffractive Multifocal IOLs. Eurotimes. 2006;9(suppl 2):2. What is 20/20 Vision? All the following represent 20/20 vision Beyond 20/20 Snellen Acuity is not sensitive enough to detect decline in quality of vision Well-lit, high-contrast images are inconsistent with many real-world visual tasks Person with reduced functional vision can read letters on Snellen chart, but may not see clearly in low light conditions Ginsburg AP. Forensic aspects of visual perception. In: Forensic aspects of vision and highway safety (1996) Lawyers & Judges Publishing Company, Inc

12 The TECNIS Multifocal Acrylic IOL Designed to reduce spherical aberration to zero Designed to correct chromatic aberration at near in all light conditions Superior near and far low-light image quality Superior near and far bright-light image quality Faster near and intermediate reading speed High spectacle independence High patient satisfaction Allows transmission of healthy blue light Accommodating IOLs Conceptualized by Stuart Cummings in 1980s First implant 1991, 11 designs since Appeal: Correct presbyopia in a natural, physiological way Designed to displace forward as ciliary muscle contracts Forward movement of IOL increases dioptric power of pseudo-phakic eye Four Generations of Crystalens Crystalens Crystalens HD - 4 th generation Crystalens AO - 5 th generation 1st Generation FDA Approved 2003 The AT45 2nd Generation Released Aug 2005 The AT45-SE 3rd Generation Released Nov 2006 The AT50-SE 4 th Generation Released July 2008 HD 500-SE Made of silicone material called Biosil Modified plate-style implant with 5 mm optic Overall loop to loop length 11.5 mm, longer version available in 12 mm for powers below 17 D Suggested starting point: AO HD A constant: ACD: Crystalens AO Properties Monofocal IOL Aberration-free aspheric optic reduces spherical aberration Makes lens less sensitive to the effects of decentration B&L Accommodating Toric IOL Cylinder options from 1.25 to 2.75 D Clinical trial N=229 eyes UCDVA > 20/ % UCIVA > 20/ % Rotation < 5 o in 96.1% eyes MRSE within 0.5D of target in 74.8% MRSE within 1.0D of target in 94.0% Residual astigmatism < 1.0D of target in 95.5% 12

13 Primary Ciliary Muscle Primary Mechanism of Action Optic Movement Relaxed Accommodation causes the ciliary muscles to contract Displaces the vitreous mass Forces the accommodating IOL forward Adds dioptric power to the optical system Increased Pressure Constricted Secondary Mechanism of Action: Optic Arching Capsular contraction slightly distorts the optic as it s forced anteriorly Capsular contraction changes the radius of curvature of the lens Distance Near Δ 2.50 D Crystalens Pre and Post op Pearls Crystalens Preop Targeting Distance eye: Target plano to Near eye: Target to Post op Atropine strongly recommended 1 drop at the end of surgery (1%) Provides cycloplegia for 3-5 days post op Helps keep lens stable during the early post-op period Steroids, NSAIDs control aggressive fibrotic response Steroids Maintain QID x four weeks then Slow taper: TID x 1 week, BID x 1 week, QD x 1 week NSAIDS BID to QID until gone Crystalens Accommodative Rehabilitation Mild readers (+1.00 to +1.50) Provide comfortable near vision during cycloplegia days after surgery (for each eye) Keeps lens stable during early post-op period Accommodative change between distance - near may be slow at first (intermediate at 1 wk, near at 2 wks) Don t force reading during 1 st days Patients must challenge their near vision Reading exercise (word search) booklets are given days after second eye is done Challenge intermediate and near vision Presbyopic IOL Patient Selection Motivated, well informed Realistic expectations Results vary between patients Potential complications & side effects Degree of accommodation possible (Crystalens) Unrealistic expectations Demand perfect vision Demand immediate results Near vision improves over time All surgery has inherent risk Refractive Lensectomy 13

14 Crystalens Patient Selection Patient Lifestyle and Expectations Ideal Candidates: Candidate for bilateral implantation Especially appreciated in hyperopes Patients with good or stable ocular health Patients with potential for good visual acuity in each eye Patients with corneal astigmatism less than or 0.75D *Plan for additional astigmatic correction for patients with corneal astigmatism greater than 0.75D (LRI) Patients with realistic expectations, psychologically stable (any refractive surgery patient) Know patient s lifestyle and expectations Utilize: Cataract & Refractive Lens Exchange Questionnaire or a similar questionnaire Educates patient and doctor about expectations, trade-offs Premium IOL Conversion Rates Study by Cynthia Matossian, MD (out of PA, NJ) N = 325 pts, 39% male, 61% female, age y/o Premium options: LRIs, toric IOLs, multi-focal IOLs, and accommodating IOLs Conversion Rates for eligible patients: LRIs = 84.4% Toric IOLs = 63.5% Accommodating IOLs = 38.1% Multi-focal IOLs = 25% Candidacy for any Premium option declined with age (pathology) Reasons: Cost, preference for glasses Men: 44.2% preferred glasses, 9.3 preferred monovision Women: 25.9% preferred glasses, 29.4% preferred monovision Presbyopic IOL Challenges Presbyopic / Premium IOLs Cost Surgeon experience, comfort level (discuss cost, RBA) Night vision disturbances Quality of post op near vision Contraindications Posterior pole pathology, amblyopia, irregular astig, miotic pupils, prism in Rx, corneal pathology New IOL versions Have promise Not yet available in the US Future Considerations Synchrony Dual Optic IOL Toric multi-focal IOLs AcrySof IQ ReSTOR MF Toric FDA Pre-market application 2012 Launched outside US in 2010 Light-adjustable IOLs Power adjusted after IOL implanted Results showing some increase in HOAs Capsular refilling technologies 14

15 Questions? Contact Information Bill Tullo, OD, FAAO Krystal Joyner, OD 15