Lasik Xtra: Principles and results of consecutive LASIK and CXL for the treatment of Moderate to high refractive error and PresbyLasik.

Transcription

1 Lasik Xtra: Principles and results of consecutive LASIK and CXL for the treatment of Moderate to high refractive error and PresbyLasik. Charles Ghenassia New Vision, Nice. No financial interest Avedro s 3rd International Congress on Advanced Corneal Cross-Linking. Satellite Meeting at the 4th Annual AECOS European Meeting.

2 LasikXtra: a new concept in the laser treatment of moderate to high refractive error. Corneal CXL : 2000 Keratoconus High ametropia LasikXtra: 2011 «La Passerelle» Gustave Eiffel Bordeaux. Why is the Lasik Xtra procedure still viewed with suspicion in France? The «precautionary principle» to garantee citizen safety has been written into the French Constitution, a symbol of a society that gradually gives in to the zero risk ideology. As a consequence innovation is often discouragedandhowever, Lasik Xtra: A bridge between the proven efficacy of conventional CXL already used in the treatment of keratoconus and the corneal stability targeted in the laser treatment of high ametropia. Furthermore, it can reduced the risk of corneal complications such as post op ectasia.

3 Clinical RESULTS post CXL on keratoconus and ectasia, on the reduction in astigmatism, on improvement in visual acuity and corneal stability since 2000.(efficiency,safe) a Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat L.: Collagen Crosslinking with Riboflavin and Ultraviolet A light in Keratoconus: Long term results. 241 eyes. J. Cataract Refract Surg, 2008; 34:

4 Principles: publications on the regression of high ametropia post refractive surgery. Myopic regression post refractive surgery. Significant long-term myopic regression observed after LASIK for high myopia. Daniel S. Durrie, MD. J Refract Surg. 2009;25(2): eyes ES -12,3 D from 2 to 5 yrs: 40% 1D regression, 70% at 2D. eand 91% à 3D. Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser In Situ Keratomileusis: A Prospective Randomized Clinical Trial. Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Am J Ophthalmol. 2012;154: Regression after LASIK for the treatment of myopia: the role of the corneal epithelium. (pre op 34 at 44 microns post op 34 at 111, 10 microns = 1D.) Lohmann CP1, Guell. JL Semin Ophthalmol Jun;13(2): Hyperopic regression post refractive surgery. 5-year follow-up of LASIK for hyperopia. Jaycock PD 1, O'Brart DP, Rajan MS, Marshall J. Ophthalmology Feb;112(2): Factors that influence outcomes of hyperopic laser in situ keratomileusis. Cobo-Soriano R 1, Llovet F, González-López F, Domingo B, Gómez-Sanz F, Baviera J. J Cataract Refract Surg Sep;28(9):

5 Principle: this regression can be tied to a corneal weakening 15 to 25% induced by flap creation. (Prof John Marshall) Affaiblissement cornée Flap depth Interferometric technique to measure biomechanical changes in the cornea induced by refractive surgery. Philip David Jaycock, MRCOphth address, Leon Lobo, PhD, Jamal Ibrahim, Meng, John Tyrer, PhD, John Marshall, PhD Journal of Cataract & Refractive Surgery Volume 31, Issue 1, Pages , January 2005.

6 TREAMENT PRINCIPLES and corneal biomechanics : identical increase in rigidity : 3 mw/cm 2 vs 30mW/cm2 depending on irradiation time Adapted from Krueger, Spoerl, Herekar, Rapid vs. Standard Collagen CXL with Equivalent Energy Dosing. Original online presentation link: MA-00057, Rev. A. Comparison of standard and high intensity CXL using bio-mechanical strengthening and second harmonic optical imaging. Rebecca McQuaid, JiaJun Li, Arthur Cummings, Michael Mrochen and Brian Vohnsen. Advanced Optical Imaging Group, School of Physics, University College Dublin, Belfield Campus, Dublin 4, Ireland. Biomechanical Properties of Human Corneas Following Low- and High-Intensity Collagen Cross-Linking Determined With Scanning Acoustic Microscopy. Ithar M. Beshtawi, 1 Riaz Akhtar, 2 M. Chantal Hillarby, 3 Clare O'Donnell, 4 Xuegen Zhao, 5 Arun Brahma, 6 Fiona Carley, 6 Brian Derby, 5 and Hema Radhakrishnan 1 Invest Ophthalmol Vis Sci. Aug 2013; 54(8): Published online Aug 7, doi: /iovs PMCID: PMC

7 Principle: distribution of corneal strength. Study by Randleman et Al. (Atlanta-USA) Bowman s membrane 4%. 1/3 anterior cornea 61%. This is where Lasik Extra is valuable 2/3 posterior cornea 30%. Descemet s membrane 5%. Depth-dependent cohesive tensile strength in human donor corneas: implications for refractive surgery. Randleman JB, Dawson DG, Grossniklaus HE, McCarey BE, Edelhauser HF. Emory University, Department of Ophthalmology, Atlanta, GA, USA. Jrandle@emory.edu. Journal of Refractive Surgery (Thorofare, N.J. : 1995) [2008, 24(1):S85-9]

8 Results: Lasik Xtra publications Kanellopoulos AJ. Long-term safety and efficacy follow-up of prophylactic higher fluence collagen cross-linking in high myopic laser-assisted in situ keratomileusis. Clinical Ophtalmology 2012: Progress of corneal collagen cross-linking combined with refractive surgery. Na Li, Xiu-Jun Peng, Zheng-Jun Fan. Int J. Ophtalmol, Vol 7, N 1, Feb 18,2014. Epithelial Remodeling After Femtosecond Laser-assisted High Myopic LASIK: Comparison of Stand-alone With LASIK Combined With Prophylactic High-fluence Cross-linking. Cornea Volume 0, Number 0, Month 2014 Anastasios J. Kanellopoulos, MD,* and George Asimellis, PhD*. Corneal collagen cross-linking in the stabilization of PRK, LASIK, thermal keratoplasty, and orthokeratolo. Michelle K. Nguyen and Roy S. Chuck ß 2013 Wolters Kluwer Health Lippincott Williams & Wilkins.

9 Surgical protocols are heterogeneous (from a few to 30 minutes depending on fluence) Authors Sources Impregnation UV Fluence Irradiation Time Kanellopoulos et Al. Clin. Oph sec 10 mw/cm2 180 sec Celik et Al. JCRS sec 30 mw/cm2 180 sec Tomita ASCRS sec 30 mw/cm2 90 sec Tamayo JCRS sec 30 mw/cm2 75 sec Kanellopoulos et A. JRS sec 10mW/cm2 180 sec Aslanides et Al. Clin. Oph min 3 mw/cm2 30 min Avedro protocol: 0.25% riboflavin impregnation for 1 minute. UV irradiation at 30 mw/cm 2 for 1 minute 30 UV energy profile delivered at 30 mw/cm 2

10 LasikXtra technique: adds 3 min. per eye to the standard procedure Flap creation with Femtosecond (or microkeratome). Excimer laser photoablation. 0,25% Riboflavin Instillation for 1 minute. UV irradiation at 37 mw/ cm 2 for 1min30.

11 LasikXtra indications: Should it be used for high ametropia only or can it be generalized? Consensus: Hyperopia > 3.00 D. Myopia > 6.00 D. Astigmatism > 2.50 D. Difference in astigmatism > 1.50 D between the eyes. Other indications: Patients 18/30 y.o.(every one of us know regression on young patients) Thin pachymetry < 520 without clinical signs of asymmetry. Patients with severe eye allergy. Family history of keratoconus. Retreatment for regression. Thick flap evaluated with anterior OCT. Radial keratotomy. Presbylasik to conserve the corneal shape factor in post op

12 Results: LasikXtra efficacy in hyperopic patients Authors Publications N (eyes) Followup Kanellopoulos et Al. JRS months Aslanides et Al. Clin. Oph months Inclusion criteria H < +8,00 D. Cyl < 6.00 D. H Type of Study Randomized Non randomized Results Without CXL Regression With CXL No regression Topography-guided Hyperopic LASIK With and Without High Irradiance Collagen Cross-linking: Initial Comparative Clinical Findings in a Contralateral Eye Study of 34 Consecutive Patient. Anastasios John Kanellopoulos, MD; Jonathan Kahn, MD. JRS Adjuvant corneal crosslinking to prevent hyperopic LASIK regression. Clin. Oph. 28 mars 2013

13 Results: Lasik Xtra efficacy in myopic patients Authors Publications N (eyes) Followup Inclusion criteria Type of Study Tamayo JCRS mth M Retrospective Non randomized Results Similar results in both eyes Tomita ASCRS mths M Vision stable at 1 yr Kanellopoulos et Al. Clin. Oph ,5 years M >-6.00 D. Non randomized No overcorrection Célie et Al. JCRS mths M randomized Similar results in both eyes Epithelial Remodeling After Femtosecond Laser-assisted High Myopic LASIK: Comparison of Stand-alone With LASIK Combined With Prophylactic High-fluence Cross-linking.Anastasios J. Kanellopoulos, MD,* and George Asimellis, PhD*

14 Our preliminary results 27 patients with a KXL Avedro lamp following the recommended protocol: 60 sec Vibex/ 90 sec U.V.30 mw/cm2. 13 cases of myopic treatment (26 eyes) with preop evaluation of -6,50 D. 12 cases of high hyperopia treatment (24 eyes) with preop evaluation of +3,25 D. 2 cases of presbyopic patients (4 eyes). Results after follow-up from 1 year to 3 months : Slit-lamp at D1 : No aspect different from a standard treatment. (corneas clear at D1, flaps unremarkable) No added nocivity reported. No unusual functional complaints.(1transitory photophobia ) No regression observed (but follow-up insufficient for a definite conclusion)

15 Ex.: Presbylasik Xtra for thin pachymetry? Patient: B. Palmine 50 y.o. RE: +0,75 (+0,75) 130 LE: +1,00 (+0,50) 90 Add: +1,50 Pachymetry: 480 microns??

16 Ex.: Presbylasik Xtra «a new way?» Pre op and post op Topographies Pre op asphericity: -0,08 Post op asphericity: -1,29 Patient female 56 y.o. RE: +3,25 (+1,50)90 LE: +2,75 (+0,50) 60 Conventional presbylasik In this case Presbylasik Xtra have been indicated for stability of asphericity and NV?

17 Which would you choose in this case? Nothing or PRK+CXL or Lasik Xtra? 31 yr old patient RE: (-1.75) O 20/20 No asymmetry in elevation and keratometry LE: (-4.75) 0 16/20 Inferior asymmetric keratometry and decentration in elevation

18 LASIK XTRA CONCLUSION No change to the standard lasik procedure is needed (microkeratome or femtolaser) No haze or lines lost on the best corrected visual acuity on our results No readjustment needed in our experience according to most studies. Lasik xtra should not be indicated for a cornea with suspected keratoconus (topoguided PRK plus CXL) consider legal liability. Lasik Xtra is indicated for the high ametropia and young people to improve the result stabilty in time Cost of procedure is higher. Is it a true problem to improve results? The different results show the stability of the treatment but follow up insuffisant in our studies The scope of indications should widen progressively. We start now Presbylasik Xtra for the stability of asphericity and NV in time.