WGA GUIDELINES

ISBN 10: 90 6299 219 6

ISBN 13: 978 90 6299 219 5

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© 2008, 2009 World Glaucoma Association (WGA) Published under a licence by Kugler Publications

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Table of Contents

Introduction

It is evident that in the last couple of years there has been a surge of interest in research in the fi eld of glaucoma surgery. This includes research in the improvement of conventional glaucoma surgery; trabeculectomy, and glaucoma drainage devices, as well as research in more recently introduced surgical methods and their emplacement in our range of surgical therapeutic options. Modulation of wound healing, a factor of paramount importance, has also received its share of research interest. More recently, research has embarked on identifying different surgical approaches and alternative surgical strategies.

Clinical glaucoma surgical research is currently hindered by, among other things, the lack of uniform guidelines for clinical glaucoma surgical trials reporting. This has been clearly highlighted in the last ten years by the controversy that arose from the introduction of non-penetrating glaucoma surgery (NPGS). Despite a plethora of reports currently in the literature, it is quite diffi cult to make certain and accurate evaluation of the exact location of NPGS among our options. This is mainly because of the absence of a common platform (guidelines) on which studies can be reported and thus compared.

Currently such reports are reported with diverse, variable and inconsistent methodology. This is fi rstly because such guidelines do not exist, secondly because there is no general consensus, even among the experts in the fi eld, and fi nally because basic knowledge pertaining to proper methodologies, ethical factors, and statistics are not readily available to all.

Seeing a pressing need for the creation and publication of clear and detailed guidelines for glaucoma surgical trials, the World Glaucoma Association (WGA) took the initiative to form a steering committee and to invite a working group of more than 70 leaders in the fi eld of glaucoma research. The choice of invited scientists took into consideration all aspects related to glaucoma surgical research, spanning from clinical research to economic aspects, statistics, and ethical considerations. The choice of invited scientists was also based on a well-established and active track record of research in this domain.

What you have in your hands is the result of their combined efforts, their brainchild so to speak. After months of debate, controversy, and constructive discussion this group has achieved a consensus on a myriad of topics. These guidelines were validated by the Board of Governors of the WGA, and boards and members of all of its member societies. It can only be useful if it is well adopted by the majority, if not all researchers in this vital fi eld.

The publication of these guidelines is seen by the steering committee as a fi rst step, to be followed by many others aiming to promulgating and advocating its messages.

Tarek Shaarawy

Franz Grehn

Mark Sherwood

•The MSC recognizes the importance of determining visual function before and after operative intervention to assess the outcomes of glaucoma surgery. Use of standard automated perimetry as described in several large randomized clinical trials may facilitate the comparison of results across different studies.

•The MSC recommends that investigators determine the best corrected visual acuity with the standard Snellen charts under standard conditions of distance and illumination or with previously published acuity charts, such as the Early Treatment of Diabetic Retinopathy Study.

•The MSC recognizes that several reports have identifi ed the chronic use of specifi c topical ocular hypotensive medications as risk factors for failure with trabeculectomy. The investigators are encouraged to estimate the length of exposure to each class of medications, and examine for evidence of chronic infl ammation.

•The MSC recommends masking of the surgeon and patient to the treatment being performed if this is practical; however, we also recognize that this is not possible for most glaucoma surgical procedures.

•The MSC recommends that the surgeon who performs the procedure should not evaluate the patient for the purpose of providing information that will be used to judge the success or failure of the procedure.

•When possible, the MSC strongly advocates the measurement of endpoints by skilled graders who have not been directly involved in patient care.

Introduction

The Methodology Sub-Committee (MSC) has been charged with developing guidelines for clinical studies to facilitate the acquisition of useful information to facilitate decision making in glaucoma surgery. Specifi c directives for the MSC state: The key discussion will be on how various elements in different surgical studies can be standardized so that clear comparisons can be made.

The Problem

Since currently no clear guidelines exist on methodology of design and reporting of glaucoma surgical trials, there is evident confusion as to how to draw conclusions and compare published trials.

The MSC Guidelines should assist investigators in the planning and reporting of studies that are used to evaluate glaucoma surgery, such as comparative trials, non-comparative case series, interventional case reports, and case control studies.