Innovations in Refractive Surgery

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1 Innovations in Refractive Surgery Edward E. Manche, MD Byers Eye Institute Stanford University School of Medicine Financial Interest Disclosures AMO D Best Doctors A Calhoun Vision R Avellino Laboratories D Oculeve A Presbia D Zeiss D Seros Medical A,R,P Veralas A,R Current technology: Wavefront-guided Wavefront-optimized Phakic IOL s New Technology on the Horizon Available now or soon: Advanced wavefront-guided Topography-guided SMILE surgery Corneal inlays for presbyopia 1

2 Advanced Wavefront-Guided Ablations Advantages of Advanced Wavefront- Guided Ablations Current technology proven, with exceptional results WFG technology been available for years Treats entire eye aberrations Not just corneal astigmatism Diagnostic capabilities take into account entire optical system Broad data capture Can measure all ocular aberrations HOAs FDA approved in 2015 clinical trials performed at Stanford High-Definition Sensor Maximizes Capture Rates High-definition Hartmann-Shack wavefront sensor (five times higher resolution than WaveScan system) Fourier reconstruction algorithms using up to 1257 micro-refractions over a 7 mm diameter wavefront 3x dynamic range (vs. WaveScan system): Sphere: D to D, Cylinder: up to +8.0 D Increasing resolution enables: Potential to capture more eyes Improved spot quality, reduces spot cross over effect Greater detection of HOAs Enhanced reconstruction precision Superior refractive outcomes with LASIK 2

3 High Resolution is the Key to Success WaveScan system wavefront System Model Eye idesign system high-definition wavefront idesign System s High Resolution WaveFront Sensor WaveScan system wavefront idesign system high-definition wavefront High Resolution Wavefront 3

4 High Resolution WFG LASIK Monocular 1M Postop UCVA 100% 95% 99% 100% 90% 84% 80% 70% 60% 50% 20/16 20/20 20/25 20/40 Data courtesy of Steve Schallhorn, MD Topography-Guided Ablations Topography-Guided Ablations Ablation profile combines manifest refraction & corneal topography Uses placido disk & Scheimpflug technology Topography, keratometry & pupillometry 22,000-25,000 elevation points Designed to address corneal aberrations exclusively Treat primary eyes & therapeutic (keratoconus) Previously operated symptomatic eyes: Decentered ablations Small optical zones Residual or induced corneal irregularities FDA approved 4

5 Potential Advantages of Topography-Guided Ablations Familiarity with topography Consistency of capture, less fluctuation without accommodation and centroid shift Consider angle kappa: visual axis vs. pupil centration Corneal aberrations too high for accurate WF capture Previous corneal surgery, trauma Keratoconus, or forme fruste keratoconus When you cannot or do not want to perform WFG Pupil too small Cannot relax accommodation during measurement Corneal or lens opacities Enhance postop multi-focal IOL Topography-Guided FDA Results: Myopic Eyes Excellent outcomes in primary myopia 1 : 92.7% 20/20 UCVA 68.8% 20/16 UCVA 29.6% gained >= 1 line BSCVA 98% of patients said they would have procedure again Visual symptoms (glare, halos, difficulty driving at night, light sensitivity, dry eye) improved after surgery Also approved for decentrations, enlargement of small optical zones, corneal scars, irregular ablations, & central corneal irregularities 1: Ophthalmology Web: Alcon WaveLight Allegretto Wave Eye-Q Excimer Laser Approved by US FDA for Topography-Guided LASIK Treatments, November 2013: LASIK-Treatments/ Decentration After Myopic Ablation Pre Op UCVA 20/20 Rx: x 33 (20/20) Post Op 6 Months Post PRK UCVA 20/16 Rx: x 62 (20/16) Topography Difference Ablation Pattern Courtesy of Dan Reinstein, MD 5

6 Small Incision Lenticule Extraction (SMILE) Small Lenticule Extraction (SMILE)* All femtosecond laser procedure Intrastromal procedure Can treat low, moderate and high myopia and myopic astigmatism Currently in FDA clinical trials in the U.S. Multi-center clinical trial comparing SMILE to LASIK scheduled to commence in first quarter of 2016 at Stanford *Investigational SMILE Procedure 6

7 Small Lenticule Extraction (SMILE)* Similar clinical outcomes to LASIK Potentially superior biomechanical properties less weakening of the cornea Significantly less dry eye due to sparing of the superficial cornea nerve plexus No ability to perform enhance surgeries need to perform PRK *Investigational Corneal Inlays for Presbyopia Corneal Inlays for Presbyopia Kamra Inlay 3.8 mm, opaque, biocompatible polymer with 1.6 mm clear central aperture. Pinhole effect to improve near vision. FDA approved Raindrop Inlay 2.0 mm transparent biocompatible hydrogel. Increases central corneal curvature (hyper-prolate) improving depth of focus. FDA clinical trials ongoing Flexivue Microlens Inlay 3.2 mm transparent biocompatible hydrogel with 1.6 mm central clear zone. Increases refractive index of the cornea to improve near vision. FDA- trials being conducted at Stanford 7

8 FlexiVue Microlens Transparent, hydrophilic lens Hole in center permits transfer of oxygen, nutrients to cornea Central zone is plano, peripheral zone has add power FlexiVue Inlay Procedure Postop Photos 8

9 OCT Images A Blended Bifocal Lens Uncorrected Near Visual Acuity Operated Eye (70 eyes at 12 Months) 99% of patients achieved Uncorrected Near VA of 20/40 or better at Month to 0.16 logmar (20/16 to 20/25) 0.18 to 0.38 logmar (20/30 to 20/40) 0.40 logmar (20/50 or worse) 100% 97% % of Patients 80% 60% 40% 20% 0% 83% 74% 72% 70% 62% 53% 31% 34% 27% 22% 29% 16% 16% 0% 3% 4% 4% 1% 2% 1% Preop Day 1 Week 1 Month 1 Month 3 Month 6 Month 12 *8 patients missed Month 6 visit, which may distort the visual acuity (logmar) outcome. 9

10 Best Corrected Distance Visual Acuity Operated Eye (70 Eyes at 12 Months) There was no change in Best Corrected Distance VA in the operated eye after 12 months. 100% 80% logmar 60% 40% 20% 0% to 0.16 logmar (20/16 to 20/25) 0.18 to 0.38 logmar (20/30 to 20/40) 97% 97% 87% 75% 61% 35% 24% 13% 3% 0% 4% 1% 0% 3% 0% Preop Day 1 Week 1 Month 1 Month 3 Month 6 Month 12 *8 patients missed Month 6 visit, which may distort the visual acuity (logmar) outcome. Thank You 10

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