Introduction
It is evident that in the last couple of years there has been a surge
of interest in research in the field 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 difficult 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 firstly because such guidelines do not exist,
secondly because there is no general consensus, even among the experts
in the field, and finally 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 field 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 field. The publication of these guidelines is
seen by the steering committee as a first step, to be followed by many
others aiming to promulgating and advocating its messages.
Tarek Shaarawy
Franz Grehn
Mark Sherwood
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Table of Contents
Introduction
Recommended Methodology for Glaucoma Surgical Trials, R.K.
Parrish II, D.S. Minckler, D. Lam, N. Pfeifffer and P. RojanaPongpun
Summary Points
Introduction
The Problem
I. Clinical Interventional Studies (Clinical Trials)
II. Observational Studies
III. Other Study Types
MSC Guidelines
I. Study Design (Levels of Study)
II. Baseline Pre-Operative Data
III. Procedure Methodology
IV. Post-Operative Assessment
References
Consensus on definitions of success, D.K. Heuer, K. Barton, F.
Grehn, T. Shaarawy and M. Sherwood
Summary Points
Introduction
Report
I. Intraocular Pressure Documentation
II. General Data Presentation Requirements
III. Other Possible IOP-Related Outcome Measures
IV. Visual Fields
V. Visual Acuity
VI. Complications
VII. Follow-up
Conclusions
Further Research Needed The Ethics of Innovation, A.V. Levin
and G.L. Spaeth
Summary Points
The Problem
Report
I. Clarifying the Objective
II. Conflict of Interest
III. Informed Consent
IV. Other Research Ethics Principles
Conclusions
Further Research Needed
References
Reporting post-operative complications in glaucoma surgical trials,
H.D. Jampel
Summary Points
The Problem
Report
I. Intraoperative Complications
II. General Post-operative Complications
III. Complications Specific to Trabeculectomy (Bleb-related)
IV. Complications Specific to Drainage Device Surgery
V. Complications Specific to Non-penetrating Glaucoma Surgery
Conclusions
Overview
Guidelines for economic evaluation of glaucoma surgical trials,
S. Kymes and A. Azuara-Blanco
Summary Points
Introduction
I. Methods of Economic Evaluation
II. Conducting Cost-effectiveness Analysis
III. Cost Utility Analysis
IV. Recommendations
Further Research
References
Statistical aspects of reporting glaucoma surgical studies, W.J.
Feuer
Summary Points
Introduction
Report
I. Design Considerations
II. Analysis
III. Reporting
Conclusions
Further Research Needed
References
Overview
Appendix
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