Contoura TM Vision Correction

Transcription

1 Contoura TM Vision Correction Fernando Faria Correia, Financial Disclosures: Alcon/Wavelight Cairo (Egypt) 26/01/2018 Topography-guided ablations Topography guided ablations Evolution from complicated eyes to primary eyes Regular Cornea Irregular Cornea 1

2 Don t forget! Tilt on /off High Order Aberration (HOA) Ablation Profile Difference in ablation depht between Tilt on and Tilt off. Analyze the ablation profile and predict the spherical component induced by the HOA ablation: 1. Peripheral Ablations: hyperopic-like - induction of myopia 2. Central Ablations : myopic-like induction of hyperopia 33 Topo-guided EX500 Business Use Only Contoura FDA Trial Topography guided profile for primary ablations ( to +6,0 D, Astigmatism up to 6.0 D) FDA Results the best ever for a LASIK treatment Results Overview - 30,9% gain 1 line BSCVA - 10,4 % gain 2 lines BSCVA - 34,4% achieve 20/ ,8 % achieve 20/16-92,6% achieve 20/20 Improvement of symptoms related to Lasik surgery: light sensitivity, night driving, reading ability, glare 2

3 METHODS: Thestudycomprisedpatients aged18to65yearsoldwithmyopiaor myopicastigmatism with a manifest refraction spherical equivalent (MRSE) up to 9.0 diopters (D) and astigmatism of 6.0 D or less. Patients with previous refractive surgery or abnormal topography were excluded. Corneal topographies were obtained using the Allegro Topolyzer, and laser treatment was delivered with the Allegretto Wave Eye-Q excimer laser system. Visual outcomes were evaluated postoperatively at 1day, 1week, and 1, 3, 6, 9, and 12 months. RESULTS: The clinical trial enrolled 212 patients (249 eyes). The T-CAT procedure significantly reduced themrseandcylinder, withstabilityof outcomes evident from 3to12 months after surgery. Compared withthepreoperativecorrected distancevisual acuity(cdva), thepostoperativeuncorrecteddistancevisual acuity (UDVA) improvedby1lineor morein3of eyesandthepostoperative UDVA was at least as good as the preoperative CDVA in 9 of eyes. Most visual symptoms improved after T-CAT. There were no significant treatment-related adverse events or loss of vision. ARTICLE CONCLUSION: The T-CAT procedure performed with the diagnostic device and the refractive excimerlaser systemsafelyandeffectivelyachievedpredictablerefractiveoutcomesandreducedvisual Results of topography-guided laser in situ symptoms with stableresults through 12 months. keratomileusis custom ablation treatment with Financial a refractive Disclosure: excimer Dr. Stultingisapaidconsultant laser toalconlaboratories, Inc., andwasamedical monitor for theu.s. Food anddrug Administration (FDA) clinical trial. Dr. Fant is president of R. Doyle Stulting,, Barbara S. Fant, PharmD, the T-CAT Study Group Clinical Research Consultants, Inc. (CRC), theclinical and regulatory consulting group that sponsored thefdaclinical trial. Dr. Fant and CRCweresupportedby Alcon Laboratories, Inc. SE = -4,61 ± 2, eyes D PURPOSE: To evaluatethesafety and effectiveness of topography-guided custom ablation treatment (T-CAT) to correct myopia and myopic astigmatism with laser in situ keratomileusis (LASIK). SETTING: Nine clinical sites in the USA. DESIGN: Prospective observational nonrandomized unmasked study. METHODS: The study comprised patients aged 18 to 65 years old with myopia or myopic astigmatism with a manifest refraction spherical equivalent (MRSE) up to 9.0 diopters (D) and astigmatism of 6.0 D or less. Patients with previous refractive surgery or abnormal topography were excluded. Corneal topographies were obtained using the Allegro Topolyzer, and laser treatment was delivered with the Allegretto Wave Eye-Q excimer laser system. Visual outcomes were evaluated postoperatively at 1 day, 1 week, and 1, 3, 6, 9, and 12 months. TheRESULTS: first refractive The clinical trial enrolled excimer 212 patients laser (249 eyes). was Theapproved T-CAT procedure significantly by the reduced themrseand cylinder, withstability of outcomes evident from 3 to 12 months after surgery. U.S. Food and Drug Administration for thecorrection Compared with thepreoperativecorrected distancevisual acuity (CDVA), thepostoperativeuncorrected distance visual acuity (UDVA) improved by 1 line or more in 3 of eyes and the postoperative of spherical myopia in Technological advances UDVA was at least as good as the preoperative CDVA in 9 of eyes. Most visual symptoms nowimproved allow after surgeonstoalso T-CAT. There were no significant correct treatment-related hyperopia, adverse events or loss regular of vision. CONCLUSION: The T-CAT procedure performed with the diagnostic device and the refractive excimer laser system safely and effectively higher-order achieved predictablerefractive optical outcomes aberrations and reduced visual astigmatism, symptoms with stable results through 12 months. (HOAs). Initially, custom correction of HOAs was based on aberrometry. More recently, custom treat- Financial Disclosure: Dr. Stulting is a paid consultant to Alcon Laboratories, Inc., and was a medical monitor for the U.S. Food and Drug Administration (FDA) clinical trial. Dr. Fant is president of Clinical Research Consultants, Inc. (CRC), the clinical and regulatory consulting group that sponsored based the FDA clinical on trial. corneal Dr. Fant and topography CRCwere supported by was Alcon Laboratories, introduced. 1,2 Inc. ment The J Cataract current Refract Surgstudy 2016; 42:11 18 was Q 2016designed ASCRS and ESCRSto evaluate the Supplemental material available at safety and effectivenessof topography-guided custom The first refractive excimer laser was approved by the U.S. Food and Drug Administration for the correction of spherical myopia in Technological advances now allow Q 2016 surgeons ASCRS to also and correct ESCRS hyperopia, regular astigmatism, and higher-order optical aberrations Published by Elsevier Inc. (HOAs). Initially, custom correction of HOAs was based on aberrometry. More recently, custom treatment based on corneal topography was introduced. 1,2 The current study was designed to evaluate the safety and effectiveness of topography-guided custom ablation treatment (T-CAT) using diagnostic device J Cataract Refract Surg 2016; 42:11 18 Q 2016 ASCRSand ESCRS ablation treatment (T-CAT) using diagnostic device Supplemental material available at technology that integrates noncontact topography, keratometry, and pupillometry in a single device (Allegro Topolyzer, Alcon Surgical, Inc.), T-CAT treatment planning software, and a refractive excimer laser system (Allegretto WaveEye-Q, Alcon Surgical, Inc.) for the correction of myopia and myopic astigmatism with laser in situ keratomileusis (LASIK). PATIENTS AND METHODS This prospective nonrandomized study was performed at 9 clinical sites in the United States on patients with myopia technology that integrates noncontact topography, keratometry, and pupillometry in a single device (Allegro Topolyzer, Alcon Surgical, Inc.), T-CAT treatment planning software, and a refractive excimer laser system (Allegretto Wave Eye-Q, Alcon Surgical, Inc.) for thecorrection of myopiaand myopicastigmatism with laser in situ keratomileusis (LASIK). PATIENTS AND METHODS This prospective nonrandomized study was performed at 9 clinical sites in the United States on patients with myopia /29/2018 Q 2016 ASCRS and ESCRS Published by Elsevier Inc UCVA: 20/12 (3), 20/16 (65-7) 1% loss lines CDVA, 3 gain 1 line CDVA 94,8% ± 0,50 D Different Approaches for T-CAT FDA Study Topography-modified refraction (TMR) Kanellopoulos (2016) Hybrid Lyra Protocol (2017) 3

4 Contoura FDA-Approach HOA ablation max < 10 microns HOA profile similar to trefoil/quadrifoil correction Be careful with coma Topo and Refractive axis coincident No compensation need Patient Data Gender: Male Age: 51 years Job: Police Officer Hobby: Hunter Arrhythmogenic right ventricular dysplasia No history of ocular trauma or surgery 4

5 Patient Data Pre-OP subjective Refraction: OD: OS: BCVA: OD: 6/10 (10/10 pinhole) OS: 10/10 I want to improve my distance vision! Corneal ToPography 5

6 Corneal ToMography T-CAT ablation Laser used: Wavelight EX400 6

7 6M Postoperative Data Post-Op Subjective Refraction: 180º UCVA: 10/10 BCVA: 12/10 Slit lamp: unremarkable findings 6M Postoperative Data POSTOPERATIVE PREOPERATIVE DIFFERENTIAL 7

8 Contoura LASIK (110-flap) Contoura OD Preop BCVA 1,0 (-4,25, -1,00 a 90º) Postop UCVA OD 13/10 (+0,00) WFO OE Preop BCVA 1,0 (-4,75, -1,00 a 90º) Postop UCVA OS 12/10 (+0,00) Contoura LASIK 22 eyes of 11 patients Mean age: 34,0 ± 6,15 Sphere Preop: -2,00 ± 2,32 D (+3,00 a -5,25 D) Astigmatism Preop: -0,50 ± 2,07 D (+ 0,0 a -4,25 D) Surgical Technique Femto-Lasik (FS 200, Alcon WaveLight), Flap 110 um, diameter 9,00 mm Ablation Laser Excimer EX400 (Alcon WaveLight) T-CAT Contoura 8

9 Contoura LASIK N=22 Sphere Cylinder Spherical Equivalent Preop -2,00 ± 2,32 D (+3,00 a -5,25 D) -0,50 ± 2,07 D (+ 0,0 a -4,25 D) ± 1.87 D ( a ) Postop ± 0.19 D (+0.50 a D) ± 0.33 D (+0.00 a D) ± D ( a D) 6 months Contoura LASIK 9

10 Contoura LASIK Contoura PRK N=40 Sphere Cylinder Spherical Equivalent Preop -2,32 ± 1,04 D -0,54 ± 0,44 D ± 0.21 D Postop ± 0.17 D ± 0.25 D ± D 6 months 10

11 Achieved Spherical Equivalent Refraction (D) Cumulative % Of Eyes % Of Eyes % Of Eyes Mean ± SD Spherical Equivalent Refraction (D) % Of Eyes 1/29/ % % % eyes 6 months postop Postop UDVA Preop CDVA 20/ /16 20/20 20/25 20/32 20/40 Cumulative Snellen Visual Acuity (20/x or better) Uncorrected Distance Visual Acuity % % 5% 1 Loss 3 or Loss 2 Loss 1 No Change Gain 1 Gain 2 Gain 3 or More More Change in Snellen Lines of CDVA Change in Corrected Distance Visual Acuity 8 68% 7-4 Overcorrected y = x R² = mean: -0.03±0.01 D range: to D Spherical Equivalent Attempted vs Achieved -3 Undercorrected Attempted Spherical Equivalent Refraction (D) % 13% 3% 3% < to to to to to > to to to to Postoperative Spherical Equivalent Refraction (D) Spherical Equivalent Refractive Accuracy Postop Preop % 8% 8% to to % 13% 8% 3% 3% to to to to to Pre #REF! 1 (40) 3 (40) 6 (40) Refractive Astigmatism (D) Time After Surgery (months) Refractive Astigmatism Stability of Spherical Equivalent Refraction Take-Home Messages Topography guided ablation for primary ablations Safe Efficient FDA Trial the best outocomes ever for a LASIK treatment Be careful and conscious in patient selection Topography scans quality (tear film) See HOAs profile Remember: there is a WFO profile... 11

12 Take-Home Messages Refractive Adjustment Sphere HOA Map: Trefoil / Tetrafoil / Coma pattern Maximum ablation < 10,0 µm No refractive adjustment Maximum ablation > µm Do a Refractive adjustment Maximum ablation > 16 µm WFO Thank you for your attention f.faria.correia@gmail.com 12