WIXLIB

Andrew Holzman, MD FACSRegional Medical DirectorTLC Tysons Corner, Rockville, and CharlottesvilleAssistant Professor of OphthalmologyUniversity of Virginia School of MedicineGeorgetown University School of MedicineContributing Author: Jen Weigel, OD, FAAO

Disclosures I have no financial interest in the following subjectmatter.

Current Excimer Laser Technology AMO VISX STAR S4 IR excimer laser Advanced CustomVue procedureNo longer at any TLC Center Alcon WaveLight EX500 excimer laser Currently the excimer laser platform of choice for all TLCCenters across North AmericaI was using this platform long before TLC followed my lead

VISX STAR S4IR ExcimerLaser ** We no longer usethis laser system.

More Detailed Information Wavefront technologywas originally developedfor use in high poweredtelescopes to reducedistortions when viewingdistant objects in space. This technology has beenapplied to laser visioncorrection.

Precision Identifies and measuresimperfections in anindividual’s eye 25 times moreprecisely than standardmeasurements for glasses andcontact lenses.

Hartmann-Shack AberrometerCCDImageOutcoming WaveCCD-Camera Lens Array

WaveScan WaveFront System 240 Hartmann-Shack data points analyzed AMO Fourier algorithm provides high resolutionanalysis of the wavefront error Equivalent to 20th order Zernicke measurement

Advanced CustomVue The marriage of theWaveScan Systemand the STAR S4 Excimer LaserSystem

Key Points Concerning CustomVue Technology Able to treat aberrations that were previously unmeasurable Each eye has its own unique “fingerprint”, which can be measuredand treated Better chance of achieving “personal best vision” Minimizes any potential night time aberrations. Larger pupils (7.5 mm or more) were among most satisfied groupof patients! Iris registration increases alignment accuracy and precision

AMO RefractiveLaser Suite:IntraLase VISX STARS4 IR Excimer Laser

AlconWaveLightEX500 ExcimerLaser ** We offer this lasersystem at TLC TysonsCorner, Rockville, andCharlottesville.

Why is the WaveLight EX500 different? Fastest laser in the United States today Features technology that accurately controls thecreation and precise delivery of every single laser pulse Uses wavefront principles right from the start andallows customization of the standard treatment

How fast is the WaveLight EX500? 500 Hz repetition rate Ablates 1D tissue in 1.4 sec Increased speed means decreased: Stromal dehydration Flap shrinkage Sensitivity to eye movements Patient fixation fatigue

Ablation with WaveLight EX500

Wavefront-Optimization Based on empiric research, WaveLight developed analgorithm that adds additional pulses into theperiphery to pre-compensate for the induction ofspherical aberrations in the periphery

Peripheral Pulse Control In the periphery of the eye, the laser pulse hits thecornea at an angle Due to the angle of incidence, light is partiallyreflected away from the eye This results in energy losses up to 80% If losses are not compensated for, post- op ablationprofile does not match the natural corneal shape

Peripheral Pulse ControlA circular beamIs being projectedOn the corneaNormal ablationReflectionCircular in the centreReduced Ablation, lowFluence

Peripheral Pulse Control Reduces induced spherical aberration andsecondarily reduces the incidence of post opnightime glare. Larger optical zones with a more prolate post opcorneal shape.

Large, true optical zonesBlue effectiveoptical zoneGreen transitionzone

Controlling thermal load Thermal-Optimized Shot Distribution Varies the distribution of shots to minimize overlap Only every 5th shot overlaps with the first in the series Reduces thermal load1 5342

Eye Tracking System 1050 Hz multi-dimensional eye tracker synchronizedat 500 Hz Movement tracking with only 2 ms latency Dynamic pupil tracking from 1.5 mm to 8.00 mm

AlconWaveLightFS200/EX500RefractiveLaserSuiteNemo helps keeppatients calm in sx

New Excimer Laser Technology:Topography-Guided Treatments First introduced 2002-2003 “Topography-based ablation profiles allow cornealregularization with respect to an assumed idealcorneal surface while correcting refractive error byincorporating the manifest refraction into thetreatment algorithm.”From Tan, et al. Clinical Results of Topography-based Customized Ablations for Myopia and Myopic Astigmatism. JRS, Vol 28, No 11, 2012.

Visual Aberrations Optical irregularities that can reduce quality of vision: Lower-order aberrations Myopia, hyperopia, astigmatism Higher-order aberrations Coma, trefoil, spherical aberration Aberrations of the visual system result in, most commonly: Blur Glare Halos Diplopia Difficulty with night vision

Wavefront-guided vs Topo-guided Wavefront-guided systems measure the aberrations ofthe ENTIRE visual system Cornea, lens, retina All of these aberrations are compensated for on thecornea with a wavefront-guided excimer laser Could potentially create a more irregular cornea aftertreatment, if the lens and retina contribute the majorityof aberrations

Wavefront-guided vs Topo-guided Topo-guided systems measure the aberrations of thecornea only– Treatment seeks to smooth out the corneal surface and createsymmetry Reduces corneal irregularities which accounts for 90% ofhuman visual aberrations Advantages over wavefront-guided measurements Covers larger area of corneaNot affected by pupil sizeNot affected by accommodative statusMore reliable than wavefront measurements on highly abberatedcorneasDoes NOT put all of the eye’s aberrations onto the cornea Cataract surgery implications

Wavefront-guided vs Topo-guided Topo-guided uses combination of myopic andhyperopic treatments based on the topography--- thisapproach yields better visual results AND removes lesstissue. Tissue sparing is key advantage as highly aberratedeyes treated with Wavefront require a lot of tissueremoval. Topography is more reproducible than a Wavescansince pupil size and accommodation aren’t variables.

Topo-guided refractive treatments Corneal topography gives no information about thespherical or astigmatic error of the eye, so topo-guidedtreatments cannot be based just on topography! Software is needed which combines the topo and therefractive information together to generate the patternon laser shots that will improve the vision.

Alcon FDA Approval FDA approval of Alcon system – 09/27/2013 Three-part system to achieve topo-guided treatment AllegrettoWave Eye-QExcimer Laser AllegroTopolyzerVario topo-guidedCustomAblationTreatment (TCAT) planningsoftwareAll of my TLC Centers – Tysons Corner, Rockville, and Charlottesville – are nowoffering topography-guided laser technology. We were selected as pre-launch centers.

Allegro Topolyzer Vario Similar to how the WaveScan feeds information into theVISX excimer laser system Placido disc system Placido disc system with 22,000 elevation points - standarddeviation of 3 microns on a 1200 micron elevation Highly accurate digital system - accounts for pupil shifts,cyclorotation . Has a REFRACTIVE MAP – highlights aberrations of thecornea and their influence on the refractive state. Feeds topographic info directly into the EX500.

Topolyzer VarioPhotos by Lori Kranz, COA

Topolyzer Vario Can be used to analyze corneas for topo-guidedtreatment Learning curve for technicians in obtaining scans Very tear film dependent Harder to obtain on those with prominent brow/deepset eyes, larger nose Requires variable positioning of the patient’s head

Vario Overview Screen

Pupil and Limbal RecognitionConfirmation

Poor pupil recognition

Poor pupil recognition

Poor limbal recognition

Image area vs OZ sizePoor tearfilm qualityleads todistortionsin the pt’stopography

Tear filmdependent With a good tear film,the mires are perfectlysymmetrical Similar to manualkeratometry

Tear filmdependent With a poor tear film,the mires are distortedin dry areas

Compare examinations

Compare examinations

Contoura Vision Officially announced at American Academy ofOphthalmology meeting – November 15, 2015 Awaiting commercial launch for topo-guided forMarch 2016 Allows use with EX500

Topo-guided Treatment Parameters For topo-guided treatment: At least 18 years of age or older Official FDA approval is for “normal” corneas Spectacle prescription of: Up to -8.0 D myopiaUp to -3.0 D astigmatismUp to -9.0 D SE myopia with astigmatismStable rx for the last year Not yet for hyperopes or mixed astigmatism

Custom Ablation Treatment (T-CAT) Proprietary software to develop topography-guidedtreatment Creates large uniform optical zones Removes more tissue vs wavefront-optimized ablation Could be used for (as off-label treatment): Previous decentrations Increase small optical zones Irregular ablations from previous treatments Post-RK cases Post-keratoplastic cases Asymmetric bow-ties that might still be “normal”

Alcon Topo-Guided Clinical Study Prospective, non-randomized, multi-center, phase IIIstudy 10 study sites across the US Objective: Evaluate safety and effectiveness ofWaveLight topo-guided system for treatment of Manifest refraction HOA and asphericity Based on corneal topography data

Alcon Topo-Guided Clinical Study Adverse Events Total of 6 adverse events reported 4 transient/temporary decrease in vision withresolution by end of study 1 decreased vision secondary to blunt force trauma onday 4 post-op 1 RD, not related to surgical procedure

Alcon Topo-Guided Clinical Study 3-month post-op data 99.2% - UCVA 20/40 or better 92.7% - UCVA 20/20 or better 65% - UCVA 20/16 or better34% - UCVA 20/12.5 or better

Alcon Clinical Study: UCVA

Alcon Clinical Study: BSCVA

Alcon Clinical Study: Visual Sx

Alcon Topo-Guided Clinical Study 3-month post-op “marked” or “severe” visual symptom with incidence 5% at one-month post-op Dryness 7% at one-month vs 4% baselineLight sensitivity 7% at one month vs 5% baseline “marked” or “severe” visual symptom with incidence 5% at three-month post-op: None

Alcon Topo-Guided Clinical Study “Traditional” LASIK symptoms like glare/halos,difficulty with night driving, light sensitivity, anddryness improved after topo-guided treatment Confirmed by questionnaires at 6-12 months post-op Continued improvement with time

Post-op reporting is important We track all of our results using a software programcalled IBRA In order to enter data, we need the following from you: For 1-month and 3-month post-op UCVA OD and OS MR OD and OS even if your patient is 20/20 UCVA! BCVA OD and OS Incomplete data sets do not allow us to track dataproperly!

Our TG results (n 12 of 52) 12 complete data sets out of 52 possible TG patients Send in your post-op reports so our data betterrepresents whatour patients areactually getting and seeing!

WFO vs TG resultsBelow: Contouraresults based on 12 (of32 possible) cases.Above: WFO resultsbased on 751 (of 1832possible) cases.

Nidek EC-5000 Excimer Laser Received FDA approval for topo-assisted treatment on09/30/2013 – just 3 days after the WaveLight approvalNidekEC-5000ExcimerLaser RefractivePower/CornealAnalyzerOPD – ScanIII CustomAblationSoftwareFinal Fit

Nidek EC-5000 Excimer Laser For topo-assisted treatment: At least 21 years of age or older Spectacle prescription of: Myopia between -1.0 to -4.0 DAstigmatism between -0.5o to -2.0 DUp to SE between -1.0 to -5.0 D

Goals for Topo-Guided Treatments Reduce irregular astigmatism Creates a more regular corneal surface Make the cornea more symmetrical with respect to the visualaxis Improve previously-reduced BCVA Not necessarily to improve UCVA Sometimes may have to reduce UCVA to improve overallquality of vision (ie, enlarging an optical zone) Secondary correction could then be used to improve UCVA Improve quality of vision