2/7/18. Disclosures: Laser K s: Keratectomy to Keratomileusis with a SMILE. Who Patients Are Listening to

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1 Disclosures: Laser K s: Keratectomy to Keratomileusis with a SMILE Glaukos Equinox Alcon Mitch Ibach OD, FAAO Vance Thompson Vision Who Patients Are Listening to Optometrist 36% People who've had surgery 27% Respondents who: - have already scheduled - will definitely have - will probably have - may have surgery Family and friends 11% Specialist / Surgeon 8% Internet 7% Newspapers/magazines 5% Other 7% VisionWatch US Study Who Patients Are Listening to Optometrist 36% Who is a good candidate for refractive surgery? Respondents who: - have already scheduled - will definitely have - will probably have - may have surgery People who've had surgery Family and friends Specialist / Surgeon Internet Newspapers/magazines 11% 8% 7% 5% 27% Anatomical Optical Psychological Other 7% VisionWatch US Study 1

2 Does the technology dictate? Or is it something else? Procedural Selection Current options provide almost unlimited selection Nearly every patient accommodated Selection paramount to success Excimer laser selection: what is important? Refractive status Corneal status Lenticular status 55 old year vs. 25 year old 2

3 2/7/18 PRK Photorefractive Keratectomy PRK Post-op Surface ablation to reshape cornea & treat MRX 60/40 rule (Best vision 3-4 months PO) Approved for myopia (14.00D), hyperopia & astigmatism (6.00D). Comfortable -9.00D Pain, tearing, photophobia 3-4 days BCL inserted Utilizes the excimer laser Antibiotic QID, steroid QID, NSAID 2-3x No flap, epithelium must be removed Scraping, brushing, dilute alcohol, laser BCL: to remove or not to remove? Epithelial Ridge Epithelial Defect Frequent lubrication (comfort) LASIK Sub-epi corneal laser treatment Approved for myopia (11.00D), hyperopia (6.0D) & astigmatism (6.00D) Utilizes Femtosecond laser = Flap Excimer laser = tissue ablation Microkeratome (now rare, thicker, less predictable) Myopic Tx: central flattening Hyperopic Tx: central steepening, laser peripherally 3

4 2/7/18 LASIK 90/10 rule (best vision ~ 1months) Moderate pain/discomfort 3-4 hrs Antibiotic QID, steroid QID, ATS Dryness can limit best VA PO concerns: See pictures Jeng, B., Stewart, J., & McLeod, S. (2004). Relapsing Diffuse Lamellar Keratitis After Laser In Situ Keratomileusis Associated With Recurrent Erosion Syndrome. Archives of Ophthalmology, 122(3), Conventional Laser Correction Diffuse Lamellar Keratitis Stage I: infiltrate not involving the pupil Corrects the sphere and cylinder (low order aberrations) Stage II: infiltrate involving the pupil 0.25 D steps Patient s wavefront NOT considered Stage III: infiltrate encompassing flap with aggregation over central flap (clumping) Stage IV: flap melt Linebarger E, JCRS. Jul 2000 Wavefront Analysis Retina Lens Iris Wavefront Guided Laser Correction Cornea Wavefront (whole eye optics) to design the ablation profile Designed to change the lower orders and reduce PATIENTS SPECIFIC higher order errors (Customized treatment profile to reduce exhisting HOA s) Infrared laser Patient implications: for patients with pre-existing higher-order aberrations PRK, LASIK, SMILE, Phakic IOL 4

5 Wavefront Optimized Laser Correction Correct the sphere and cylinder with minimally induced spherical aberration Population norms for aberration profiles and HOA s. (Preserve asphericity) Patient Implications: good option for patients who have normal topography and low levels of higher-order aberrations o 110 eyes o Both groups mean pre-op MRx sph with 1.00D cyl o Equal RMS HOA (Avg. Pre-op 0.35) o No intra- or postop flap complications either group 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% WFG vs. WFO Lasik 100% Lasik Visual Acuity Results at 1 year 100% 87% 78% 78% 67% UCVA 20/32 UCVA 20/20 UCVA 20/16 Wavefront Guided Wavefront Optimized US WVL 16 E 0656 He, L., Liu, A., & Manche, E. (2014, June). Wavefront-Guided Versus Wavefront-Optimized Laser in situ Keratomileusis for Patients With Myopia: A Prospective Randomized Contralateral Eye Study. American Journal of Ophthalmology,157(6), Topography Guided Laser Correction Uses corneal data/corneal shape to personalize the ablation profile Can use data from: Placido disc/vario Patient implications: Can reliably measure highly aberrated topographies that wavefront sensors do not measure Goal: normalize the corneal surface rather than customizing the corneal surface Contoura Vision System: Devices Used WaveLight Topolyzer Vario Diagnostic Device WaveLight EX500 Excimer Laser System Laser Notebook + T-CAT Software Objective 1. Anterior-surface normalization 2. Improved visual rehabilitation BENEFITS OF TOPOGRAPHY-GUIDED TREATMENTS WITH CONTOURA VISION 1 Static (WF dependent on accommodation) Accurate & reproducible (many more data points than WF) Independent of pupil size (unlike WF) Able to produce better peripheral data than WFG treatments Derived from the cornea, where most aberrations arise Able to reliably measure highly aberrated corneas that wavefront sensors cannot measure Centered on the corneal apex, rather than the center of the pupil 1. Results from FDA T-CAT-001 clinical study for topography-guided vision correction (with the 400 Hz ALLEGRETTO WAVE Eye-Q Excimer Laser). 5

6 Comparison of WFO vs Topo Guided What about OSD? Does the presence of OSD (specifically corneal involvement) make a difference in procedural selection? Which technologies are most/least dependent on OSD? MOST dependent LEAST dependent Wavefrontguided Topo-guided standard Jain, A., Malhotra, C., Pasari, A., Kumar, P., & Moshirfar, M. (2016, September). Outcomes of topography-guided versus wavefront-optimized laser in situ keratomileusis for myopia in virgin eyes. Journal of Cataract and Refractive Surgery, 42, Market Scope Q Lasik Cases by Technology 7.1% 1.9% SMILE? 40.7% 50.3% Wavefront optimized Wavefront guided Conventional Topography guided Source: Market Scope Refractive Surgeon Survey Report Q SMall Incision Lenticule Extraction What is SMILE and Why? Laser Patient Supporting System (PSS) Platform FDA approved à -0.50D to -8.00D myopia à 0.50D astigmatism Decrease laser induced DES Maintain corneal biomechanics Decrease corneal nerve damage SMILE Procedure Femtosecond Laser Small disc or cookie of stromal tissue Side cut superior Surgeon removes disc of tissue Cornea flattens around 6

7 SMILE Post-op 75/25 rule (Best vision 4-6 weeks PO) Pain, tearing, photophobia 3-4 hours Antibiotic QID & steroid QID Frequent lubrication PO Concerns: Lenticule fragement, epiingrowth, TIME SMILE Characteristics and Possible Benefits FDA Study Refractive Accuracy: Predicted MRSE at 12 mo. 80% smaller side-cut and 30% smaller cap cut vs. LASIK. Upper corneal layers remain intact potentially greater biomechanical stability. Small incision (2-4mm) potentially fewer transected nerves, reduced incidence of dry eye. Dry Eye Prospective Randomized Trial comparing 50 femto LASIK pts to 50 SMILE pts* Preop and 3 month postop Tear Breakup Time Tear Osmolarity Moshirfar M, McCaughey MV, Reinstein DZ, et al. Small-incision lenticule extraction. J Cataract Refract Surg. 2015;41(3): * Ganesh et al. Refract Surg. 2014;30(9): ] 7

8 Corneal Biomechanics SMILE PRK LASIK 75% 68% 54% Refractive Surgery Dominant Procedures Procedure numbers RK PRK LASIK versus SMILE 80 s 90 s TOTAL STROMAL TENSILE STRENTH Reinstein, D., Archer, T., & Randleman, J. (2013, July 1). Mathematical Model to Compare the Relative Tensile Strength of the Cornea After PRK, LASIK, and Small Incision Lenticule Extraction. Journal of Refractive Surgery, 29(7), Data source: FDA Website Patient Satisfaction With Vision Correction 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 63% 60% 61% 54% 40% 88% 88% 84% 80% 77% 77% Contact Lens Control LASIK after Contacts LASIK after Glasses Baseline 1 year PO 2 years PO 3 years PO Wavefront Guided Conventional It s Good to Have Options Wavefront Optimized Topography Guided SMILE Femto Price, M., Price, D., Bucci, F., Durrie, D., Bond, W., & Price, F. (2016, August). Three-Year Longitudinal Survey Comparing Visual Satisfaction with LASIK and Contact Lenses. Ophthalmology, 123(8). 8