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Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials

Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual fi...

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Autores principales: Wu, Zhichao, Medeiros, Felipe A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5861110/
https://www.ncbi.nlm.nih.gov/pubmed/29559700
http://dx.doi.org/10.1038/s41598-018-23220-w
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author Wu, Zhichao
Medeiros, Felipe A.
author_facet Wu, Zhichao
Medeiros, Felipe A.
author_sort Wu, Zhichao
collection PubMed
description Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17–19% and 39–40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials.
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spelling pubmed-58611102018-03-26 Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials Wu, Zhichao Medeiros, Felipe A. Sci Rep Article Visual field testing is an important endpoint in glaucoma clinical trials, and the testing paradigm used can have a significant impact on the sample size requirements. To investigate this, this study included 353 eyes of 247 glaucoma patients seen over a 3-year period to extract real-world visual field rates of change and variability estimates to provide sample size estimates from computer simulations. The clinical trial scenario assumed that a new treatment was added to one of two groups that were both under routine clinical care, with various treatment effects examined. Three different visual field testing paradigms were evaluated: a) evenly spaced testing, b) United Kingdom Glaucoma Treatment Study (UKGTS) follow-up scheme, which adds clustered tests at the beginning and end of follow-up in addition to evenly spaced testing, and c) clustered testing paradigm, with clusters of tests at the beginning and end of the trial period and two intermediary visits. The sample size requirements were reduced by 17–19% and 39–40% using the UKGTS and clustered testing paradigms, respectively, when compared to the evenly spaced approach. These findings highlight how the clustered testing paradigm can substantially reduce sample size requirements and improve the feasibility of future glaucoma clinical trials. Nature Publishing Group UK 2018-03-20 /pmc/articles/PMC5861110/ /pubmed/29559700 http://dx.doi.org/10.1038/s41598-018-23220-w Text en © The Author(s) 2018 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Wu, Zhichao
Medeiros, Felipe A.
Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title_full Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title_fullStr Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title_full_unstemmed Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title_short Impact of Different Visual Field Testing Paradigms on Sample Size Requirements for Glaucoma Clinical Trials
title_sort impact of different visual field testing paradigms on sample size requirements for glaucoma clinical trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5861110/
https://www.ncbi.nlm.nih.gov/pubmed/29559700
http://dx.doi.org/10.1038/s41598-018-23220-w
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