What now, when Presbyopia sets in? Minoru Tomita, MD, PhD Executive Director Shinagawa LASIK Center, Tokyo, JAPAN

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1 What now, when Presbyopia sets in? Minoru Tomita, MD, PhD Executive Director, Tokyo, JAPAN

2 Financial disclosure Travel expenses for the ASCRS meeting were paid by Ziemer and AcuFocus, Inc.

3 Presbyopia: Correction OptionsNow!! Conductive Keratoplasty(CK) Intracor Monovision LASIK PresbyLASIK Multifocal IOLs Accommodating IOLs KAMRA Inlay

4 KAMRA Intracorneal Inlay Characteristics 8,400 holes for oxygen and nutrition flow 3.8mm diameter 1.6mm central aperture 5 µm thick First developed in 2002 Currently in FDA clinical trials Made from PVDF (PolyvinylideneFluoride) The AcuFocus corneal inlay is designed with a tiny aperture and a small opening in the center, which creates a pinhole effect. This improves the depth of focus, allowing the eye to see near and intermediate objects more clearly without limiting distance vision.

5 Patient Selection for KAMRA Inlay Hyperopes Simultaneous LASIK with KAMRA Implanting the Inlay at 200µm depth after Excimer Laser ablation Presbyopes Emmetropes Myopes Pseudophakes Initially, KAMRA inlay surgery using a pocket was only for emmetropic patients. With SIM LASIK, emmetropesare no longer the only candidates for KAMRA surgery. Now we can also treat hyperopic, myopic, and pseudophakic patients. KAMRA Inlay using a pocket Implant the Inlay into a pocket 200µm deep I will talk about 1 year results of SIM LASIK with Kamra inlay for 1535 cases in ASCRS 2011.

6 The Number of Total SIM LASIK with KAMRA Surgeries: Monthly and Accumulated Monthly Number Accumulated Since we started performing SIM LASIK with KAMRA surgeries in September 2009 through February 2011, the total number performed is over 2,000.

7 There are other candidates for the KAMRA inlay.

8 Expanded Patient Selection Presbyopes Hyperopes Emmetropes KAMRA Inlay SIM LASIK Myopes Pseudophakes KAMRA Inlay using a pocket Post-LASIK eyes KAMRA Inlay using a pocket in PL patients with or without excimer laser ablation

9 Where are the Post-LASIK patients?

10 in Tokyo, JAPAN We have performed approx. 810,000 LASIK cases since being established in 2004.

11 Awards: High volume Center Ziemer Award in 2009 thru 2010 for the highest number of refractive treatments worldwide SCHWIND AMARIS Award for the highest treatment volume worldwide in 2009 Top IntraLASE Volume Customer (2005 through 2008) For the highest treatment volume worldwide on the ALLEGRETTO Wave EYE-Q laser system (2006 through 2008)

12 Femtosecond Lasers IntraLase FS60 and ifs (AMO, USA) FEMTO LDV and Crystal Line (Ziemer, Switzerland) Excimer Lasers ALLEGRETTO wave Eye-Q (Alcon, USA) AMARIS (SCHWIND, Germany) Visx star S4 IR (AMO, USA) 19 Units 15 Units 20 Units 11 Units 3 Units Other procedures also available: Surface ablation (PRK, LASEK, EpiLASIK) Intracorneal Ring Segment Phaikic IOL Multi-focal IOL CK (Conductive keratoplasty) KAMRA Intracorneal Inlay

13 Prices for Both Eyes We charge high price for LDV surgery, compare to intralase surgery HZ Crystal Line (Ziemer, Switzerland) AMARIS (SCHWIND, Germany) ,000Yen (US$3,100) 500HZ FEMTO LDV (Ziemer, Switzerland) AMARIS (SCHWIND, Germany) ,000Yen (US$2,600) FEMTO LDV (Ziemer, Switzerland) ALLEGRETTO wave Eye-Q (Alcon, USA) ,000Yen (US$2,100) IntraLase FS60 or ifs (AMO, USA) ALLEGRETTO wave Eye-Q (Alcon, USA)

14 Monthly Number Total LASIK Surgeries using FemtoLDV and Crystal Line: Monthly and Accumulated Accumulate d Since we started using FemtoLDV in February 2009 through February 2011, the total number of surgeries is over 233,000.

15 What if the post-lasik patients become Presbyopic?

16 Presbyopia Treatment: KAMRA Inlay in Post-LASIK patients Purpose To evaluate the safety and efficacy of implanting the KAMRA(AcuFocus Inc., Irvine, California) intracornealinlay for the treatment of presbyopia in post-lasik patients. The KAMRAinlay is currently under FDA clinical trial and is available for use in Japan. This study is followed by an Ethical Board Committee in Japan. All the patients have read and signed informed consent forms.

17 Subjects and Methods From November 2010 to February 2011, 24 patientswere implanted with the KAMRA intracornealinlay in the non-dominant eye which previously had LASIK surgery. Non-dominant eye (Implanted eye): Mean age ±SD (range) Gender Eye Follow-up period: Corneal pocket was created from 200 to 230 µmthickness using the pocket software by Ziemer Femto LDV 53.0 ±3.5 (45 to 59) years old 33% Female, 67% Male 42% Right Eye, 58% Left Eye 3 months

18 AcuFocus Centration Diagnostic System AcuTarget System The AcuTargetSystem is used to guide surgeons on the proper placement of the KAMRA inlay. Preoperative Examination Identify the first purkinjiand the center of the pupil Inlay vs. Purkinje: -24µm(x), -229µm(y) Inlay vs. Pupil: -219µm(x), -144µm(y) During the Surgery Guide the surgeon as the inlay is placed in real time (this feature coming soon) Post-op Examination Compare attempted and achieved inlay positions

19 Pocket Creation Program

20 Surgical Technique KAMRA Inlay surgery in post-lasik patientswithout excimerlaser correction

21 Surgery Technique KamraInlay surgery in post-lasik patientswith excimerlaser correction

22 Results: Mean Data (Implanted Eye) n UDVA (Snellen) UNVA 30cm (Jaeger) SE (Diopter) (Mean ±SD) BCDVA (Snellen) BCNVA 30cm (Jaeger) Pre-op 24 20/16 J ± /16 J1 1W 24 20/16 J ± /16 J1 1M 9 20/20 J ± /16 J1 3M 9 20/16 (+0) P= J 3 (+5 lines) P= ŷ ± /16 J1 At 3 months, UDVA reached 20/16 and UNVA achieved J3 (a gain of 5 lines). ŷ Statistical differences between pre-op and 3 months in UNVA

23 UDVA Implanted Eyes (Snellen) 100% of the patients achieved 20/20 or better at 3 months.

24 UNVA Implanted Eyes (Jaeger) 30cm At 3 months, 89% of the patients achieved J3 or better.

25 Questionnaire: Are you satisfied? At 3 months, 100% of the patients are satisfied with the outcome. * n = 9 at 3 months

26 Questionnaire: Dependence on reading glasses? At 1 and 3 months, dependency on reading glasses have decreased in 100% of the patient. * n = 9 at 3 months

27 Discussion The mean UDVA remained 20/16 while mean UNVA improved 5 lines at three months. A majority of the patients were satisfied and reported a significant decrease in their dependence on reading glasses. In our experience, the rate of severe dry eye was lower in these post-lasik presbyopicpatients when compared to the rate for presbyopicpatients treated with SIM LASIK with KAMRA Surgery. The three month results of this prospective study demonstrate that KAMRA intracornealinlay implantation with or without excimerlaser ablation is a safe and effective treatment option for post-lasik presbyopic patients.

28 Conclusions FemtoLDV pocket program is effective for implanting KAMRA inlay for post-lasik patients. The KAMRA inlay successfully provided functional near vision for post- LASIK patients. As post-lasik patients develop presbyopia, there will be more candidates for KAMRA surgery. According to the questionnaire, at postoperative 3 months patients reported high satisfaction with their results and only a few patients still need their reading glasses.

29 Thank you

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