1. Sample Size Requirements of Glaucoma Clinical Trials When Using Combined Optical Coherence Tomography and Visual Field Endpoints

    Sample Size Requirements of Glaucoma Clinical Trials When Using Combined Optical Coherence Tomography and Visual Field Endpoints

    Glaucoma clinical trials using visual field (VF) endpoints currently require large sample sizes because of the slowly-progressive nature of this disease. We sought to examine whether the combined use of VF testing and non-invasive optical coherence tomography (OCT) imaging of the neuroretinal tissue could improve the feasibility of such trials. To examine this, we included 192 eyes of 121 glaucoma participants seen at ≥5 visits over a 2-year period to extract real-world estimates of the rates of change and variability of VF and OCT imaging measurements for computer simulations to obtain sample size estimates. We observed that the combined use ...

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