ArticleScientific reports2019
Sample Size Requirements of Glaucoma Clinical Trials When Using Combined Optical Coherence Tomography and Visual Field Endpoints.
Article in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes.American journal of ophthalmology · 2022Trial
- Artificial Intelligence-Guided Endpoint Selection for Neuroprotection Trials in Glaucoma.American journal of ophthalmology · 2026Article
- A Phase I Randomized Trial of Topical Insulin for Glaucoma: Safety and Efficacy Outcomes.Ophthalmology science · 2026Article
- Short-term Detection of Fast Progressors in Glaucoma: The Fast Progression Assessment through Clustered Evaluation (Fast-PACE) Study.Ophthalmology · 2024Article
- Barriers to IOP-independent treatments in glaucoma clinical trials.Eye (London, England) · 2023Article
- A cross-sectional study to assess the clinical utility of modern visual function assessments in patients with inherited retinal disease: a mixed methods observational study protocol.BMC ophthalmology · 2023Article
- A potential primary endpoint for clinical trials in glaucoma neuroprotection.Scientific reports · 2023Article
- Neurofilament Light Chain in Aqueous Humor as a Marker of Neurodegeneration in Glaucoma.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- Fundus-controlled perimetry (microperimetry): Application as outcome measure in clinical trials.Progress in retinal and eye research · 2021Review
- Article
- Big data in visual field testing for glaucoma.Taiwan journal of ophthalmologyReview
- Opportunities for Improving Glaucoma Clinical Trials via Deep Learning-Based Identification of Patients with Low Visual Field Variability.Ophthalmology. GlaucomaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 of VF and OCT endpoints led to a 31-33% reduction in sample size requirements compared to using VF endpoints alone for various treatment effect sizes. For example, 189 participants would be required per group to detect a 30% treatment effect with 90% power with combined VF and OCT endpoints, whilst 276 and 285 participants would be required when using VF and OCT endpoints alone respectively. The combined use of OCT and VF endpoints thus has the potential to effectively improve the feasibility of future glaucoma clinical trials.
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