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.
Laser-assisted in-situ keratomileusis (LASIK) versus photorefractive keratectomy (PRK) for myopia (Review) Shortt AJ, Allan BDS, Evans JR This is a reprint of a Cochrane review, prepared and maintained
Published: 01 February 2013 2013 Faculty of 1000 Ltd Advances in lens implant technology Daniel Kook 1 *, Anselm Kampik 1, Alois K. Dexl 2, Nicole Zimmermann 3, Adrian Glasser 4, Martin Baumeister 5 and
OPTOMETRIC CLINICAL PRACTICE GUIDELINE Care of the Patient with Visual Impairment (Low Vision Rehabilitation) OPTOMETRY: THE PRIMARY EYE CARE PROFESSION Doctors of optometry (ODs) are the primary health
Mesothelioma CLINICAL TRIALS Information for Patients and Families identifying and evaluating experimental treatments table of contents Pg. 2... Phases of a Clinical Trial Pg. 3... Mesothelioma and Clinical
Guideline for Industry The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Longterm Treatment of Non-Life- Threatening Conditions ICH-E1A March 1995 GUIDELINE FOR INDUSTRY
Clinical Trials: What You Need to Know Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe
Department of Health and Human Services OFFICE OF INSPECTOR GENERAL MOST CRITICAL ACCESS HOSPITALS WOULD NOT MEET THE LOCATION REQUIREMENTS IF REQUIRED TO RE-ENROLL IN MEDICARE Daniel R. Levinson Inspector
Prepared for Virtual Hold Technology June 2006 The Total Economic Impact Of Virtual Hold s Virtual Queuing Solutions Project Director: Dan Merriman TABLE OF CONTENTS Executive Summary...4 Purpose...4 Methodology...4
National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If
AMERICAN HEALTH CARE ASSOCIATION 2012 QUALITY REPORT Improving Lives by Offering Solutions for Quality Care. AHCA advocates for quality care and services for frail, elderly and disabled Americans, serving
Technology Assessment Technology Assessment Program Effectiveness of Cochlear Implants in Adults with Sensorineural Hearing Loss Prepared for: Agency for Healthcare Research and Quality 540 Gaither Road
What American Teens & Adults Know About Economics Prepared for: The National Council on Economic Education Project Directors: Dana Markow, Ph.D., Senior Research Director Kelly Bagnaschi, Senior Research
Guide to Small Business Communications Guide to Small Business Communications Brought to you by 1 Clear, Simple, & to the Point. Technology can often be confusing and challenging to decipher. As a small
THE GROWTH OF PRIVATE MEDICAL INSURANCE MARKET IN JAPAN Takahito Otomo Mitsui Sumitomo Insurance Company Limited, Tokyo, Japan Abstract. In Japan, aging of population is progressing rapidly, due to rising
Annual general meeting in A/S Report of the Board of Directors and Management CHAIRMAN OF THE BOARD JENS BAGER 2013/14 was the first full year after the acquisition of King Systems and a year which saw
NCARB BY THE NUMBERS June 2012 NCARB by the Numbers 2012 By the National Council of Architectural Registration Boards. All rights reserved. No part of this document may be reproduced, stored in a retrieval
Summary Internet surveys allow the researcher to dynamically tailor a survey based on how a respondent answers questions. Dynamic surveys learn about the respondent each time a response is submitted. Using
Five predictive imperatives for maximizing customer value Applying predictive analytics to enhance customer relationship management Contents: 1 Introduction 4 The five predictive imperatives 13 Products
WYOMING WORKERS SAFETY & COMPENSATION DIVISION Pilot Program for Spinal Injury Treatment Optimal Outcomes with Cost Containment for Spine Services Written by Karen C. Nelson, PT, MS, MD and David A. Roberts,
Tesla Motors, Inc. Fourth Quarter & Full Year 2013 Shareholder Letter Record 6,892 Model S vehicles sold and delivered in Q4 World s highest Consumer Reports customer satisfaction score of 99/100 Q4 auto
TREASURY INSPECTOR GENERAL FOR TAX ADMINISTRATION Reduced Budgets and Collection Resources Have Resulted in Declines in Taxpayer Service, Case Closures, and Dollars May 8, 2015 Reference Number: 2015-30-035
Chapter 4. Product Selection and Standardization Contents Chapter 4. Product Selection and Standardization 4-1 Chapter at a Glance 4-3 4.1 UNDERSTANDING PRODUCT SELECTION AND STANDARDIZATION 4-4 What is
2 COMMUNICATION, MANAGEMENT AND HEALTH GOALS AND CONTENTS The University of Lugano (USI), Switzerland, in collaboration with Virginia Polytechnic Institute and State knowledge and skills to Acquire the
Getting to the Goal Suicide as a Never Event in New York State August 2013 New York State Office of Mental Health Division of Quality Management The New York State Office of Mental Health Division of Quality