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Improving the Power of Glaucoma Neuroprotection Trials Using Existing Visual Field Data

Montesano, G. ORCID: 0000-0002-9148-2804, Quigley, H. and Crabb, D. P. ORCID: 0000-0001-8754-3902 (2021). Improving the Power of Glaucoma Neuroprotection Trials Using Existing Visual Field Data. American Journal of Ophthalmology, 229, pp. 127-136. doi: 10.1016/j.ajo.2021.04.008

Abstract

PURPOSE: Selecting reliable visual field (VF) test takers could improve the power of randomized clinical trials in glaucoma. We test this hypothesis via simulations using a large real world data set.

DESIGN: Methodology analysis: assessment of how improving reliability affects sample size estimates.

METHODS: A variability index (VI) estimating intertest variability was calculated for each subject using the residuals of the regression of the mean deviation over time for the first 6 tests in a series of at least 10 examinations for 2,804 patients. Using data from the rest of the series, we simulate VFs at regular intervals for 2 years. To simulate the neuroprotective effect (NE), we reduced the observed progression rate by 20%, 30%, or 50%. The main outcome measure was the sample size to detect a significant difference (P < .05) at 80% power.

RESULTS: In the first experiment, we simulated a trial including one eye per subject, either selecting randomly from the database or prioritizing patients with low VI. We could not reach 80% power for the low NE with the available patients, but the sample size was reduced by 38% and 49% for the 30% and 50% NE, respectively. In the second experiment, we simulated 2 eyes per subject, one of which was the control eye. The sample size (smaller overall) was reduced by 26% and 38% for the 30% and 50% NE by prioritizing patients with low VI.

CONCLUSIONS: Selecting patients with low intertest variability can significantly improve the power and reduce the sample size needed in a trial.

Publication Type: Article
Additional Information: © 2021. This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/
Publisher Keywords: Glaucoma, Visual field, Perimetry, Neuroprotection, Clinical trial
Subjects: R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
R Medicine > RE Ophthalmology
Departments: School of Health Sciences > Optometry & Visual Science
Date available in CRO: 01 Sep 2021 08:22
Date deposited: 1 September 2021
Date of acceptance: 12 April 2021
Date of first online publication: 24 April 2021
URI: https://openaccess.city.ac.uk/id/eprint/26509
[img] Text - Accepted Version
This document is not freely accessible until 24 April 2022 due to copyright restrictions.
Available under License Creative Commons Attribution Non-commercial No Derivatives.

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