Small Incision Lenticule Extraction (SMILE)

Transcription

Small Incision Lenticule Extraction (SMILE)

Walter SekundoEditorSmall Incision LenticuleExtraction (SMILE)Principles, Techniques, ComplicationManagement, and Future Concepts

EditorWalter SekundoDepartment of OphthalmologyPhilipps University of MarburgandUniversitätsklinikum Giessen & Marburg GmbHMarburgGermanyISBN 978-3-319-18529-3ISBN 978-3-319-18530-9DOI 10.1007/978-3-319-18530-9(eBook)Library of Congress Control Number: 2015945165Springer Cham Heidelberg New York Dordrecht London Springer International Publishing Switzerland 2015This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part ofthe material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilarmethodology now known or hereafter developed.The use of general descriptive names, registered names, trademarks, service marks, etc. in this publicationdoes not imply, even in the absence of a specific statement, that such names are exempt from the relevantprotective laws and regulations and therefore free for general use.The publisher, the authors and the editors are safe to assume that the advice and information in this bookare believed to be true and accurate at the date of publication. Neither the publisher nor the authors or theeditors give a warranty, express or implied, with respect to the material contained herein or for any errorsor omissions that may have been made.Printed on acid-free paperSpringer International Publishing AG Switzerland is part of Springer Science Business Media(www.springer.com)

ContentsPart IBasic Principles1Femtosecond Laser Keratomes for Small IncisionLenticule Extraction (SMILE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Mark Bischoff and Gregor Strobrawa2Wound Healing After ReLEx Surgery . . . . . . . . . . . . . . . . . . . . . . . . . 13Yu-Chi Liu, Donald T-H Tan, and Jodhbir S. Mehta3Corneal Nerve and Keratocyte Response to ReLEx Surgery . . . . . . . 27Leonardo Mastropasqua and Mario NubilePart IIClinical Development and Current Techniques4Brief Historical Overview of the Clinical Developmentof ReLEx Surgical Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Marcus Blum and Walter Sekundo5Current Technique and Instrumentation for SMILE . . . . . . . . . . . . . . 55Ekktet Chansue6Refining Results with SMILE: Tips and Tricks . . . . . . . . . . . . . . . . . . . 67Sri Ganesh7Overview of Clinical Results for Low and Moderate Myopia . . . . . . . 75Kimiya Shimizu, Kazutaka Kamiya, Akihito Igarashi,Hidenaga Kobashi, Rie Ikeuchi, and Walter Sekundo8Astigmatism Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Marcus Blum and Walter Sekundo9Clinical Results in High Myopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Anders Ivarsen and Jesper Hjortdal10Complications After SMILE and Its Management IncludingRe-treatment Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Rupal Shahv

viContents11Management of Laser Settings for Better SMILE Surgery . . . . . . . . 107Bertram Meyer and Rainer Wiltfang12Advantages and Disadvantages of Different Cap Thicknesses . . . . . . 113Jose L. Güell, Paula Verdaguer, Honorio Pallás, Daniel Elies,Oscar Gris, and Felicidad ManeroPart IIIClinical Science Related to SMILE13The Key Characteristics of Corneal Refractive Surgery:Biomechanics, Spherical Aberration, and CornealSensitivity After SMILE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Dan Z. Reinstein, Timothy J. Archer, and Marine Gobbe14Centration in SMILE for Myopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Apostolos Lazaridis and Walter Sekundo15How to Improve the Refractive Predictability of SMILE . . . . . . . . . . 157Jesper Hjortdal, Anders Vestergaard, and Anders Ivarsen16Evaluating Corneal Cut Surface Quality in SMILE . . . . . . . . . . . . . . 169Jon Dishler, Noël M. Ziebarth, Gregory J.R. Spooner,Jesper Hjortdal, and Sonia H. Yoo17Collagen Characteristics and Refractive Outcomes . . . . . . . . . . . . . . 179Kathleen S. Kunert, Marcus Blum, Thabo Lapp,and Claudia Auw-HädrichPart IVFuture Concepts18 SMILE for Correction of Very High Myopia (Higher than 10 D) . . . . 185Osama Ibrahim, Moones Abdalla, Amro Saeed,Kitty Mohammed, and Ibrahim Ahmed19Hyperopic Correction by ReLEx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193Walter Sekundo, Dan Z. Reinstein, Kishore Pradhan,and Marcus Blum20Concept of Reversible Corneal Refractive Surgery(Lenticule Reimplantation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201Debbie Tan and Jodhbir S. Mehta21SMILE in Special Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217Moones Abdalla and Osama IbrahimPart V22Marketing and Patient CommunicationHow to Promote SMILE Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 235Jean-François Faure and Bertram MeyerErratum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E1

Author BiographiesMark Bischoff is Director, Research and Development for Refractive Lasers, atCarl Zeiss Meditec AG. He joined ZEISS in 2002, where he has worked on thedevelopment project for the femtosecond laser system VisuMax and the SMILEprocedure. In 2004, he became manager of this project and in 2006 head of thesystems engineering team. Since 2008, he has been the director of R&D for refractive lasers. Mark Bischoff received his doctorate in physics in 2000 from theFriedrich Schiller University Jena. He then joined the manufacturer of femtosecondfiber lasers, IMRA America, Inc. in Ann Arbor, MI (USA), before he went to theUniversity of Jena as postdoc and leader of an industry project.vii

viiiAuthor BiographiesJodhbir S. Mehta is Head of the Tissue Engineering and Stem Cell Group at theSingapore Eye Research Institute and Head of the Corneal Service and SeniorConsultant in the Refractive Service of the Singapore National Eye Center (SNEC).He has academic affiliations with DUKE-NUS GMS.He has won 25 national and international awards including those at AAO andARVO. His interests lie in corneal transplantation—penetrating keratoplasty, lamellar keratoplasty, endothelial keratoplasty, femtosecond laser technology, cornealimaging, corneal infections, corneal refractive surgery, keratoprosthesis surgery,ocular drug delivery systems, and corneal genetics. He has authored over 210 peerreviewed publications and 9 book chapters and given over 210 oral and posterpresentations. His research work has developed nine patents, two of which havebeen commercialized and licensed to companies.

Author BiographiesixLeonardo Mastropasqua is Full Professor, Diseases of the Visual System, Facultyof Medicine and Surgery, “G. d’Annunzio” University of Chieti-Pescara. Currently,he is Head of the National High-Technology Center in Ophthalmology and theCenter of Excellence in Ophthalmology, National President of the OphthalmologySociety of Italian Universities (SOU), President of the Italian Council of UniversityProfessors of Ophthalmology, Scientific Advisor of the Directive Council of theItalian section of IAPB (International Agency for the Prevention of Blindness), andBoard Member of the EUCORNEA Society.He has authored over 240 original scientific articles, book chapters, and monographs in ophthalmology, 125 of which are published in peer-reviewed journalsincluded in the Journal Citation Reports.His principal fields of interest include refractive surgery, corneal pathologies andsurgery, cataract surgery, glaucoma, and advanced ophthalmic imaging. He doesmore than 4,000 surgical procedures per year (anterior and posterior segment) andapproximately 2,000 refractive procedures.

xAuthor BiographiesMarcus Blum was born 1 August 1960 in Kassel and grew up in Karlsruhe,Germany. After military service, he started his medical education at the Universityof Heidelberg and was trained in the Department of Ophthalmology at Heidelberg(by Prof. H.E. Völcker). In 1994, he took the board exam and moved to Jena as afellow (under Prof. J. Strobel). He was appointed Associate Professor at theUniversity of Jena in 1999. Dr. Blum was involved in building up a technologynetwork focusing on new technologies for ophthalmology in Jena. In 2001, hebecame head of the Ophthalmology Department at the HELIOS Klinikum Erfurt.He is clinical investigator for Carl Zeiss Meditec.

Author BiographiesxiEkktet Chansue, MD is the Medical Director of TRSC International LASIKCenter in Bangkok, Thailand. After finishing his Cornea, External Disease andRefractive Surgery fellowship in St. Louis, MO, in 1993, he taught at the RamathibodiHospital Faculty of Medicine, Mahidol University, Bangkok, for several years. Dr.Chansue performed the first LASIK in Thailand (and probably in South East Asia)in 1994 and has since performed more than 30,000 LASIKs. Dr. Chansue also performed the first ReLEx SMILE in Thailand in 2010. He designed the ChansueReLEx Dissector, an instrument to aid in the separation and freeing of the lenticuleduring the ReLEx procedure.

xiiAuthor BiographiesSri Ganesh is Chairman and Managing Director, Nethradhama Hospital Pvt. Ltd,BangaloreHe received his basic medical education from Bangalore University and completed his postgraduate training at Regional Institute of Ophthalmology, Bangalore.He did observership in Phacoemulsification and Lasik at Sheppard Eye Centre, LV,Nevada, USA.He is recognized for his expertise in cataract and refractive surgery and has performed over 50 live surgeries at various national and international conferences. Hehas a special interest in latest technology such as the femtosecond laser-assistedcataract surgery and all femtosecond laser refractive correction (ReLEx SMILE).He was conferred Honorary Doctorate “Doctor of Science” by the Rajiv GandhiUniversity of Health Sciences (RGUHS) for his contribution to society in the fieldof ophthalmology during the 16th Annual Convocation of RGUHS in March 2014.He has also received many awards at various academic conferences and haspublications in national and international peer-reviewed journals.

Author BiographiesxiiiKimiya Shimizu received an M.D. in ophthalmology from Kitasato UniversitySchool of Medicine in 1976 and a Ph.D. in ophthalmology from Tokyo Universityin 1984. From 1985 to 1998, he worked as a director of Musashino Red CrossHospital. He is currently a professor and chairman of ophthalmology at KitasatoUniversity School of Medicine, where he specializes in cataract and refractivesurgery.

xivAuthor BiographiesAnders Ivarsen is consultant and assistant professor within the cornea and refractive section in the Department of Ophthalmology in Aarhus, Denmark.He received his Ph.D. on refractive surgery in 2004. He has been working activelyin the field of refractive surgery since 2000 and started performing SMILE procedures as early as 2011.Anders Ivarsen has participated in several studies on SMILE and has contributedto more than 10 papers on refractive lenticule extraction.

Author BiographiesxvRupal Shah is the Group Medical Director, New Vision Laser Centers-Centre forSight, a leading chain of vision correction centers in India. She has been a pioneerof various vision correction techniques. She was the first person to perform singleincision ReLEx and SMILE procedures in the world. Over 1200 ophthalmologistshave performed their first LASIK, Femto-LASIK, or SMILE procedures under hermentorship. She has performed surgery at more than 30 different locations aroundthe world. She practices in both Vadodara and Mumbai, India. She has severalpublications in peer-reviewed journals and has written many book chapters.

xviAuthor BiographiesBertram Meyer is a specialist in laser refractive surgery since 1992 and hasperformed SMILE procedures since 2010. He works in private clinics in Cologneand in Dubai. He has given continuous and regular lectures and updates during theannual meetings of DOG, DOC, DGII, and European Society of Cataract andRefractive Surgeons (ESCRS) about Femto-Lasik and ReLEx SMILE. He hasbeen a member of the Advisory Board for Refractive Laser Surgery for Carl ZeissMeditec for many years.

Author BiographiesxviiJose L. Güell is Founding Partner of IMO and Director of the Cornea andRefractive Surgery Department. He is Associate Professor of Ophthalmology at theAutonoma University of Barcelona, Scientific Coordinator and Professor of theAnterior Segment activities at the European School for Advanced Studies inOphthalmology (ESASO), Lugano, Past President of EuCornea (European Societyof Cornea and Surface Disease), and Specialist and Past President of the ESCRS.He has published around 190 articles on corneal surgery and diseases and refractivesurgery in national and international journals and has given lectures around theworld during the last 20 years.

xviiiAuthor BiographiesDan Z. Reinstein is the Medical Director of London Vision Clinic, AdjunctProfessor of Ophthalmology at Columbia University Medical Center, New York,and Professeur Associe en Ophtalmologie at the Centre Hospitalier Nationald’Ophtalmologie des Quinze-Vingts, Paris. He is a graduate of CambridgeUniversity. Professor Reinstein’s research focuses on using Artemis VHF digitalultrasound to improve refractive surgery, in particular using the corneal epitheliumfor keratoconus screening and therapeutic corneal refractive surgery. He is also thelead consultant to Carl Zeiss Meditec, for whom he has developed Laser BlendedVision for correcting presbyopia and has contributed to the development of ReLEx SMILE. His research has led to over 115 peer-reviewed publications, 30 bookchapters, and 500 international presentations and lectures. He was awarded theWaring Medal in 2006 and received the Kritzinger Award in 2013.

Author BiographiesxixApostolos Lazaridis is a specialist of Ophthalmology at the first Department ofOphthalmology of the National and Kapodistrian University of Athens, Greece anda research associate at the Department of Ophthalmology, Philipps University ofMarburg, Germany. Dr. Lazaridis studied Medicine in Aristotle University ofThessaloniki, Greece. After a clinical traineeship in Ophthalmology at the Universityof Berlin (Charité Campus Virchow), he started his ophthalmology residency training at Ophthalmology Clinic Dr. Georg, Bad Rothenfelde, Germany and continuedas research fellow at the Institute of Experimental Ophthalmology, University ofMünster, Germany. Dr. Lazaridis completed his residency training and dissertationat the Department of Ophthalmology, Philipps University of Marburg, Germany. Hebecame a board-certified ophthalmologist in 2014 and a fellow of the EuropeanBoard of Ophthalmology (FEBO) in 2015. His clinical, surgical and researchactivity focuses on corneal refractive surgery, keratoplasty, keratoconus and cornealwound healing.

xxAuthor BiographiesJesper Hjortdal is Clinical Professor and Consultant at the Department ofOphthalmology, Aarhus University Hospital. He graduated from Aarhus Universityin 1988 and started basic and clinical research in corneal optics, biomechanics, andrefractive surgery in 1990. In 1992 he was Visiting Research Associate at StanfordUniversity, USA. He completed his PhD study in 1995 and became Doctor ofMedicine in 1998. In 1998, Jesper Hjortdal finished specialists training inOphthalmology and was in 2000-2001 Honorary Fellow to the Cornea and ExternalDiseases at Moorfields Eye Hospital, London. Jesper Hjortdal is president for theDanish Ophthalmological Society for the European Eye Bank Association.Jesper Hjortdal has published more than 130 papers. In 2013 he received theWaring Medal for Editorial Excellence (best paper in Journal of Refractive Surgery2012).

Author BiographiesxxiJon Dishler, MD, FACS, is an American Board Certified Ophthalmologist who isrecognized for his contributions to refractive surgery for over 30 years. Awardednumerous patents and publications, Dr. Dishler also built one of the first FDAapproved excimer laser systems. He has been a clinical investigator for multipleFDA trials, most recently as the US Medical Monitor for the SMILE procedure. Jonhas contributed both as a clinical site and scientific consultant on this project. Dr.Dishler realized that the lenticules removed in the SMILE procedure provided aunique opportunity to study the femtosecond laser tissue interaction in humans.With the help of co-authors, sample tissue was imaged using a new method ofscanning electron microscopy (eSEM), the results of which are presented in thistext.

xxiiAuthor BiographiesKathleen S. Kunert is senior consultant at the Eye Hospital, Helios KlinikumErfurt, and holds a position as professor of clinical optometry at the University ofApplied Sciences Ernst-Abbe Jena in cooperation with ZVA Knechtsteden. Sheobtained her degree in human medicine from the Universität Leipzig in 1996 followed by a 3 year postdoctoral fellowship at the Schepens Eye Research Instituteand Cornea Department of Ophthalmology, Harvard Medical School, Boston, USA.In 2005, she qualified as a specialist for ophthalmology and was trained at theUniversity Eye Hospital Charité, Campus Virchow, Berlin, and the Eye Hospital,Helios Klinikum Erfurt.She published numerous papers with special focus on dry eye, ocular allergy,femtosecond laser systems used for refractive correction of different eye diseases,and studies on accommodation and presbyopia.

Author BiographiesxxiiiIbrahim Osama is a clinical Professor of Ophthalmology and Immediate PastPresident of Alexandria University, being the first elected president (2011–2014).He completed a Fellowship in Corneal and Refractive Surgery at Emory Eye Clinic,USA, and was chief of Corneal and Refractive Unit, Magrabi Eye Centers, SaudiArabia. He supervised and discussed more than 70 master’s and doctoral theses for30 years and promoted refractive surgery all over the Arab world and the MiddleEast, helping establish many centers. He is an active member of almost all prestigious ophthalmic societies in the world. He has been actively involved as a principalinvestigator and consultant for many clinical studies and research projects. He is therecipient of MEACO Distinction Award for 2012, Lifetime Achievement Award bythe American Academy of Ophthalmology (AAO, 2013), and Casebeer Award bythe International Society of Refractive Surgery (ISRS, 2012).

xxivAuthor BiographiesWalter Sekundo is Professor and Chairman, Department of Ophthalmology,Philipps University of Marburg, Germany. He studied Medicine in Frankfurt(Germany), New Orleans, and Durham (USA). He was a resident at the Universityof Bonn in Germany and a Fellow in Corneal and Refractive Surgery at MoorfieldsEye Hospital (UK) and Ocular Pathology at the University of Glasgow, UK. He alsoholds a degree of “Health Care Manager.” Prof. Sekundo has published over 100original papers, over 25 book chapters, and given over 300 presentations at nationaland international meetings. He is a reviewer for 11 ophthalmic journals and a BoardMember of “Der Ophthalmologe.” Prof. Sekundo has performed over 20,000surgical procedures in the entire field of ophthalmology and has been repeatedlynamed as one of the 30 top eye surgeons in Germany. He was the first surgeon in theworld to have performed FLEx and SMILE.

Author BiographiesxxvMoones Fathi Abdalla works as medical and research director of the InternationalFemto-Lasik Centre (IFLC), Dusit Thani Lakeveiw, Cairo. He is also employed asrefractive surgery consultant and surgeon trainer at Royal Vision Center, Alexandria,and cornea and refractive consultant at Cornea Center, Alexandria. Moones FathiAbdalla started performing SMILE since 2010. He has performed over 7000SMILE procedures, trained more than 35 surgeons in doing SMILE, and contributed in many studies concerning SMILE.

xxviAuthor BiographiesJean-François Faure is an ophthalmologist specialized in laser refractive surgery(myopia, hyperopia, astigmatism, and presbyopia), cataract surgery, glaucomasurgery, eyelid surgery, and botulinum toxin injections in the treatment of blepharospasm and wrinkle correction.He is a member of the following Scientific Societies:SFO (French Society of Ophthalmology)ASCRS (American Society of Cataract and Refractive Surgery)ESCRS (European Society of Cataract and Refractive Surgery)SAFIR (French Society of Intraocular Implants and Refractive Surgery)EUCORNEA (European Society of Cornea and Ocular Surface DiseaseSpecialists)

Ekktet Chansue , MD is the Medical Director of TRSC International LASIK Center in Bangkok, Thailand. After nishing his Cornea, External Disease and Refractive Surgery fellowship in St. Louis, MO, in 1993, he taught at the Ramathibodi Hospital Faculty of Medicine, Mahidol University, Bangkok, for several years. Dr.