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International standards of clinical trials in glaucoma surgery

Abstract

The problem of clinical trials organization has become essential in the field of modern glaucoma surgery. The development of evidence-based medicine requires a high level of reliability of obtained data, which requires a comprehensive organization and statistic level. Publication of Guidelines on Design and Reporting of Glaucoma Surgical Trials by the World Glaucoma Association and introduction of CONSORT standards into this field became first steps to solve this problem. Glaucoma surgery specifics define requirements for clinical trials in this field. Surgery success and failure criteria have to be defined in a study design. Clinical examination methods in pre- and post-operative period have to be standardized for subsequent statistical processing of received data. Statistical analysis and data visualization are essential parts of a clinical trial. Any kind of received data has to be compiled and statistically analyzed to help define its scientific value.

About the Authors

V. P. Erichev
Scientific Research Institute of Eye Diseases
Russian Federation


S. Yu. Petrov
Scientific Research Institute of Eye Diseases
Russian Federation


A. A. Antonov
Scientific Research Institute of Eye Diseases
Russian Federation


A. V. Volzhanin
Scientific Research Institute of Eye Diseases
Russian Federation


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Review

For citations:


Erichev V.P., Petrov S.Yu., Antonov A.A., Volzhanin A.V. International standards of clinical trials in glaucoma surgery. National Journal glaucoma. 2016;15(2):102-112. (In Russ.)

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ISSN 2078-4104 (Print)
ISSN 2311-6862 (Online)