Medical Director, Shinagawa LASIK Center, Tokyo, Japan Adjunct Professor, Department of Ophthalmology, Wenzhou Medical College, Wenzhou, China

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1 Medical Director,, Tokyo, Japan Adjunct Professor, Department of Ophthalmology, Wenzhou Medical College, Wenzhou, China Financial disclosure: Ziemer Group AG, Switzerland AcuFocus, CA Schwind Eye-Tech-Solutions, Germany

2 1,143,777 Femto LASIK cases since being established in in Tokyo with 5 branch clinics. We have a total of 62 doctors. Our clinics perform approx. 70% of the LASIK procedures in Japan.

3 FEMTO LDV, Crystal Line & Z6 (9 units) (Ziemer, Switzerland) IntraLase FS60 & ifs (AMO, USA) 19 Units Refractive Suite (Alcon, US) 1 Unit Visx star S4 IR (AMO, USA) AMARIS (SCHWIND, Germany) 14 Units ALLEGRETTO Wave Eye Q (Alcon, USA) 23 Units KXL System, (Avedro, USA) 11 Units 3 Units 9 Units Other procedures also available: Surface ablation (PRK, LASEK, EpiLASIK) Intrastromal corneal ring segments Phakic IOLs Multi focal IOLs KAMRA Intracorneal Inlays CK (Conductive Keratoplasty)

4 51,354 eyes have been treated with crosslinking! *February 2011 through July 2013 Monthly Accumulated

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7 The KXL system is an investigational device in the US and currently under consideration by the FDA. This study is followed by an Ethics Committee in Japan. All the patients read and signed an informed consent form.

8 Who are the LASIK Xtra Candidates? Patients with Borderline topography between LASIK and PRK Strong refractive errors (over D) -High refractive correction leads to a weaker corneal structure Atopic dermatitis -One of the major risk factors for keratoconus and keratoectasia Thin corneas, less than 480μm preoperatively

9 Patient demographics Operations conducted March 2011 ~ December 2011 Number of eyes 855 eyes of 471 patients Age 32.7 ± 8.1 years Manifest refraction spherical equivalent (MRSE) ± 1.52 Diopter (D) Range; D ~ D A prospective IRB approved evaluation of LASIK Xtra. Visual acuity, Keratometric reading, endothelial cell density (ECD) count, and the morphological change were evaluated. Optical Coherence Tomography (OCT) was taken to check for the existence of a demarcation line similar to that after conventional CXL. Patients were checked at 1 day, 1 week, 1, 3, 6 and 12 months postoperative.

10 1. Seamlessly after LASIK second 0.1% riboflavin pre-soak of the corneal stromal bed 3. Rinse any excess riboflavin away and return the flap to its original position seconds of Ultraviolet A (UVA) light at 30 mw/cm 2 was applied 30 mw/cm 2 is the Highest Irradiance Available Name KXL System (Avedro, Inc) Wavelength 365 nm Power 30 mw/cm² Riboflavin presoak time 90 sec. Riboflavin % 0.1% UV irradiation time 90 sec.

11 1.6 20/ / / / / / UDVA (logmar/snellen) Visual Outcomes / / / / / /80 CDVA (logmar/snellen) / / / NS / / / NS NS NS NS /12.5 PreOP (n=855) 1D (n=855) 1W (n=790) 1M (n=748) 3M (n=623) UDVA (logmar/snellen) 6M (n=464) 1Y (n=601) /12.5 PreOP (n=855) 1D (n=855) 1W (n=790) 1M (n=748) 3M (n=623) CDVA (logmar/snellen) 6M (n=464) 1Y (n=601) Resulted in stable vision through the 1 year follow-up.

12 Refractive Outcomes 2 MRSE (D) 46 K ave (D) NS NS 10 PreOP (n=855) 1D (n=855) 1W (n=790) 1M (n=748) MRSE (D) 3M (n=623) 6M (n=464) 1Y (n=601) 32 PreOP (n=855) 1D (n=855) 1W (n=790) 1M (n=748) Keratometry (D) 3M (n=623) 6M (n=464) 1Y (n=601) MRSE and Average K reading did not show statistically significant differences through 1 to 12 month(s) postoperative.

13 Endothelial cell density (cells/cm2) There was a significant difference observed in ECD between Pre OP and 1Y postoperative. (Paired t-test: P = ) Rearrangement of the cells may have occurred after cessation of contact lenses.

14 Morphological Change by Confocal Microscopy We found increased reflectivity in the stromal cells similar to that after conventional CXL. 2,3 Increased reflectivity Rarefaction of keratocytes Persistent stromal edema Demarcation line and the flap interface by OCT We found a demarcation line under the flap similar to that after conventional CXL. 4,5 A; Flap interface B; Demarcation line 2.J.Oscar C et al.: J Refract Surg.2010;26: Mazzotta C et al.: Am J Ophthalmol. 2008;146(4): Theo S et al.: Cornea.2006;25: Aldo C et al.: Am J Ophthalmol.2010;149:

15 The 1 year results of LASIK Xtra for Highly Myopic Patients show: LASIK Xtra was safe as it showed stable visual acuity and refraction. It could be beneficial to offer LASIK Xtra for highly myopic patients. The changes observed with confocal microscopy and OCT examinations were similar to those observed after conventional CXL. This could be a sign that corneal strengthening occurred. Further long term follow-up studies are necessary to confirm these results and to evaluate the effects of LASIK Xtra.

16 Thank you!! E mail : lasik.com 16

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