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Handbook of Clinical Trials in Ophthalmology Handbook of Clinical Trials in Ophthalmology AK Gupta ms (aiims) fams Director (Academic) ICARE Eye Hospital and Postgraduate Institute, NOIDA, UP, India Director (Academic) Shroff Eye Centre, Kailash Colony, New Delhi, India Formerly Director Guru Nanak Eye Centre, New Delhi, India Dean Maulana Azad Medical College, New Delhi, India Dean Medical faculty, University of Delhi, India Vinod Kumar Aggarwal ms (mamc) dnb mnams frcs (Glasg) Assistant Professor University College of Medical Sciences and GTB Hospital Delhi, India Neha Goel ms (mamc) dnb frcs (Glasg) Consultant (Vitreoretina and Uvea) ICARE Eye Hospital and Postgraduate Institute NOIDA, UP, India Foreword Barun Kumar Nayak ® JAYPEE BROTHERS MEDICAL PUBLISHERS (P) LTD New Delhi • London • Philadelphia • Panama ® Jaypee Brothers Medical Publishers (P) Ltd Headquarters Jaypee Brothers Medical Publishers (P) Ltd 4838/24, Ansari Road, Daryaganj New Delhi 110 002, India Phone: +91-11-43574357 Fax: +91-11-43574314 Email: [email protected] Overseas Offices J.P. Medical Ltd Jaypee-Highlights Medical Publishers Inc 83, Victoria Street, London City of Knowledge, Bld. 237, Clayton SW1H 0HW (UK) Panama City, Panama Phone: +44-2031708910 Phone: + 507-301-0496 Fax: +02-03-0086180 Fax: + 507-301-0499 Email: [email protected] Email: [email protected] Jaypee Medical Inc Jaypee Brothers Medical Publishers (P) Ltd The Bourse 17/1-B Babar Road, Block-B, Shaymali 111 South Independence Mall East Mohammadpur, Dhaka-1207 Suite 835, Philadelphia, PA 19106, USA Bangladesh Phone: + 267-519-9789 Mobile: +08801912003485 Email: [email protected] Email: [email protected] Jaypee Brothers Medical Publishers (P) Ltd Shorakhute, Kathmandu Nepal Phone: +00977-9841528578 Email: [email protected] Website: www.jaypeebrothers.com Website: www.jaypeedigital.com © 2014, Jaypee Brothers Medical Publishers All rights reserved. No part of this book may be reproduced in any form or by any means without the prior permission of the publisher. Inquiries for bulk sales may be solicited at: [email protected] This book has been published in good faith that the contents provided by the authors contained herein are original, and is intended for educational purposes only. While every effort is made to ensure accuracy of information, the publisher and the authors specifically disclaim any damage, liability, or loss incurred, directly or indirectly, from the use or application of any of the contents of this work. If not specifically stated, all figures and tables are courtesy of the authors. Where appropriate, the readers should consult with a specialist or contact the manufacturer of the drug or device. Handbook of Clinical Trials in Ophthalmology First Edition: 2014 ISBN: 978-93-5090-774-0 Printed at Dedicated to All those involved in conduction of these trials Foreword Medical science is constantly changing and has evolved over centuries. Each discipline in medicine has developed into many subspecialties. Today, we are in an era of evidence-based medicine, for which clinicians have to keep themselves updated in the knowledge and research related to their particular field. All clinicians can neither have access to full text of all articles nor have the time to go through them. Handbook of Clinical Trials in Ophthalmology is authored by AK Gupta, Vinod Kumar Aggarwal and Neha Goel, in response to a timely perceived requirement. They have collected and summarized the major clinical trials in different subspecialties in the field of ophthalmology. Each of the nineteen chapters deals with important clinical trials of a particular subspecialty. The format presented includes all the essential aspects of a trial, such as purpose of study with background, study design, number of subjects with inclusion and exclusion criteria, and outcomes measures. It is followed by results with conclusion nicely summarized without any distortion of facts. The special feature is the summary of important facts in a tabular format at the end of each chapter giving a “bird’s eye view” of all the trials included in that chapter. Authors have also given the expanded form of all the abbreviations used in the text in the beginning of the book for ready reference. Authors have done a commendable job on the topic which is need of the hour and I personally salute them. All ophthalmologists, whether a clinician, a postgraduate student or a teacher, will find this book useful. No ophthalmologist can afford to miss this book and should keep it in the bookshelf for ready reference. I am thankful to the authors for sharing this book with me before publication and giving me the honour of writing a foreword. Barun Kumar Nayak MD Head, Department of Ophthalmology P. D. Hinduja National Hospital and Medical Research Centre Mumbai, India Editor: Journal of Clinical Ophthalmology and Research Past Editor: Indian Journal of Ophthalmology Preface The impact of clinical trials on the practice of medicine cannot be under- estimated. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. In order to form opinions and make judgments, clinicians require access to reliable sources of evidence. Ideally, this data should be easily accessible to the practitioners in order to implement the latest findings in their respective field. Also, for students in this area of specialization, this data is an invaluable resource of information on previously conducted research. Not only does this add to their clinical acumen, this knowledge is frequently tested in all examinations and reviews. Although the clinical trials in the field of ophthalmology are numerous, yet one would need to spend considerable time and effort to locate each relevant one and learn from it. This book offers every clinical ophthalmologist complete guidance as it compiles the results of the latest multicenter clinical trials in the practice of ophthalmology with relevant references. The trials have been organized into chapters, covering all ophthalmic subspecialties. Each pertinent trial is described under similar subject headings/styles and has been formatted accordingly for easy reading and recall. A summary at the end of each chapter has been provided for easy reference. All the trials have been listed alphabetically and indexed at the end. Such significant consolidated information can be uniquely valuable to a wide audience. The individual studies can be traced for details as the book provides all the relevant references. This handbook is not distorting any facts or adding any other perspective, suggestions or implications. It is an effort to provide a convenient and quick reference for the vast data available. All the major and latest clinical trials have been recorded but it must be understood that the list is not exhaustive. Knowledge of these trials in clinical practice can lead to significant improvements in patient care and patient outcome in ophthalmology. General ophthalmologists will have the current standard of patient care across the spectrum of ophthalmology at their fingertips, in an easily digestible format. Residents reviewing the major subspecialties for board exams, comprehensive ophthalmologists keeping abreast of all areas of ophthalmology, and subspecialists interested in future direction of their area of focus, will all find this book a good reference. A K Gupta Vinod Kumar Aggarwal Neha Goel