LASIK XTRA : WHAT DOES THE LITERATURE SHOW?
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1 LASIK XTRA : WHAT DOES THE LITERATURE SHOW?
2 Lasik Xtra: Restoring corneal strength Creation of the LASIK flap weakens the cornea by as much as 30%. Lasik Xtra treatment protocols are designed to apply sufficient stiffening to restore the cornea to its pre-lasik level of stiffness, without excessive change
3 Lasik Xtra: Corneal strengthening during LASIK The goal of Lasik Xtra is to restore biomechanical integrity to corneas that have been weakened by refractive surgery to achieve stable, predictable visual outcomes in order to: Reduce the risk of post- LASIK refractive regression Reduce the risk of post- LASIK ectasia
4 Lasik Xtra: Corneal strengthening during LASIK The LASIK flap is left open following excimer laser ablation Dextran free riboflavin is applied to the stromal bed immediately after ablation Riboflavin is rinsed from the eye, and the flap is repositioned as usual UVA illumination is applied through the closed flap for 90 seconds at 30mW/cm 2
5 Lasik Xtra: Maintaining Predictability Pan-corneal treatment KXL system with homogenous beam profile and large depth of focus is used to cross-link the entire central 9mm of the cornea Uniform treatment across the large treatment zone restores stability without redistributing corneal stresses (no shape change) This differs from treatment of keratoconus, where the cornea has a focal region of weakness Center to edge beam uniformity insures consistent results
6 LASIK + CORNEAL CROSS-LINKING: KEY POINTS What do we know: LASIK weakens the cornea Cross-linking scffens the cornea What Do We Need to Know? Can we safely add cross-linking to LASIK? Can we achieve predictable refraccve outcomes with Lasik Xtra? Can Lasik Xtra improve corneal stability?
7 Lasik Xtra: Clinical Results
8 Lasik Xtra: Safety Published studies show no endothelial cell loss Celik HU, Alagöz N, Yildirim Y, et al. Accelerated corneal crosslinking concurrent with laser in situ keratomileusis. J Cataract Refract Surg. 2012;38(8): Kanellopoulos AJ. Long-term safety and efficacy follow-up of prophylactic higher fluence collagen cross-linking in high myopic laser-assisted in situ keratomileusis. Clin Ophthalmol. 2012;6: Tomita M, Yoshida Y, Yamamoto Y, Mita M, Waring G. In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: One-year results. J Cataract Refract Surg. 2014;40(6): Mazzotta C, Balestrazzi A, Traversi C, Caragiuli S, Caporossi A. In vivo Confocal Microscopy Report after Lasik with Sequential Accelerated Corneal Collagen Cross-Linking Treatment. Case Rep Ophthalmol. 2014;5(1): Wu Y, Tian L, Wang L, Huang Y. Efficacy and Safety of LASIK combined with Accelerated Corneal Collagen Cross-Linking for Myopia: Six Month Study. Biomed Res Int. 2016;
9 Lasik Xtra: Safety Superficial corneal crosslinking during laser in situ keratomileusis Theo G. Seiler, MD, Isaak Fischinger, MD, Tobias Koller, MD, Viktor Derhartunian, MD, Theo Seiler, MD, PhD J Cataract Refract Surg 2015; 41: In a study applying 9mW/cm2 CXL, a greater post-operative inflammatory response was seen in the Lasik + CXL group during the first postoperative week. DLK resolved in all eyes by 1 week. No eyes in either group lost CDVA at 1 year post-operatively.
10 Lasik Xtra: Predictability Adjunctive Collagen Crosslinking of the Residual Stromal Bed in LASIK: Finite Element Analysis of Impact on Refractive Outcome and Surgically Induced Deformation Seven I, Roy ASR, Dupps BJ, Cleveland Clinic Cole Eye Institute. ARVO; 2014 SIMULATION: -4.25D LASIK procedure, wavefront optimized ablation profile with OZD 6.5mm. CXL of the central 9mm of the RSB with depth 200 micron and stiffening factor 1.5. Tangential curvatures of anterior surface points were calculated IOP 15MMHG IOP 30MMHG LASIK 15MM (microns) LASIK + CXL 15MM (microns) LASIK 30MM (microns) LASIK + CXL 30 MM (microns) PRE-OP LASIK P<0.05 P<0.05 RESULT: LASIK with CXL of the RSB employing a 50% increase in anterior RSB stiffness contributed less than 0.25D of hyperopic effect to the postoperative refractive error and significantly reduced corneal displacements after LASIK. LASIK + Cross-linking
11 Lasik Xtra: Predictability In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: One-year results Minoru Tomita, Yuko Yoshida, Yusuke Yamamoto, Mariko Mita, George Waring IV, JCRS Vol 40, JUNE 2014
12 Lasik Xtra: Predictability Spherical Equivalent Refractive Accuracy LASIK vs. LASIK Xtra at 3 Months Jerry Tan, MD Eur J of Ophthalmology 2015
13 Lasik Xtra: Predictability Short-term Variance of Refractive Outcomes After Simultaneous LASIK and High-Fluence Cross-linking in High Myopic Correction Tommy C. Y. Chan, FRCS; Marco C. Y. Yu, PhD; et. al. J Refract Surg. 2016;32(10): While the previous studies of Lasik Xtra conducted with 30mW/cm 2 irradiance (KXL) show equivalent or better predictability than LASIK alone, this study conducted using 18mW/cm 2 irradiance (CXL-Vario) demonstrated better predictability in the LASIK-only group than in the Lasik + CXL group.
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15 Lasik Xtra: Stability In vivo confocal laser microscopy of morphologic changes after simultaneous LASIK and accelerated collagen crosslinking for myopia: One-year results Minoru Tomita, MD, PhD, Yuko Yoshida, BA, Yusuke Yamamoto, MD, Mariko Mita, MD, PhD, George Waring IV, MD. J CATARACT REFRACT SURG - VOL 40, JUNE 2014
16 Lasik Xtra: Stability Comparison of prophylactic higher fluence corneal cross-linking to control, in myopic LASIK, one year results. Kanellopoulos AJ, Asimellis G, Karabatsas C. Clin Ophthalmol Nov 27;8:
17 Lasik Xtra: Stability Topography-guided Hyperopic LASIK With and Without High Irradiance Collagen Cross-linking: Initial Comparative Clinical Findings in a Contralateral Eye Study of 34 Consecutive Patients. Kanellopoulos AJ, Asimellis G Journal of Refractive Surgery 2012 Adjuvant corneal crosslinking to prevent hyperopic LASIK regression. Aslanides IM, Mukherjee AN. Clin. Ophthalmol. 2013
18 Confocal Microscopy Hyper-reflectivity and keratocyte apoptosis to a stromal depth of µm Keratocyte repopulation complete by 6 months postoperatively No endothelial damage was observed Findings suggest microstructural changes similar to those found with conventional cross-linking Mazzotta C, Balestrazzia A, Traversia C, Caragiulia S, Caporossib A Case Rep Ophthalmol 2014;5:
19 Lasik Xtra: Review Ar0cles
20 LASIK + CORNEAL CROSS-LINKING: LASIK XTRA KEY POINTS What do we know: LASIK weakens the cornea Cross-linking scffens the cornea What Do We Need to Know? Can we safely add cross-linking to LASIK? Can we achieve predictable refraccve outcomes with Lasik Xtra? Can Lasik Xtra improve corneal stability?
21 THANK YOU
Lasik Xtra Clinical Data Overview. MA-00354 Rev A
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