ArticleOphthalmology science
Short-term Assessment of Glaucoma Progression in Clinical Trials Using Trend-based Visual Field Progression Analysis.
Article in Ophthalmology science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To evaluate the effect of disease stage, frequency and clustering of visual field (VF) tests, inclusion of 1 or both eyes, and 1 (1 arm; before and after a treatment) or 2 groups (2 arms; treatment and control arm) on sample size calculation in clinical trials. Design: Clinical cohort study. Participants: A series of VFs were simulated based on test-retest VF data in the early, moderate, and advanced stages of glaucoma with 231, 204, and 226 eyes, respectively. Methods: The mean of mean deviation (MD) slope was -0.75 decibels (dB)/year before treatment initiation in the 1-arm trial, and in the control group in the 2-arm trial. Visual field measurements were scheduled as 8 times in 2 years. Main Outcome Measures: Sample size calculation in clinical trials. Results: In the 1-arm trial, when only 1 eye was used in each patient, the 80% probability of significance in the moderate stage was observed with sample size = 70 eyes. Disease in the early stage and inclusion of both eyes decreased this number to 30 eyes; these decreasing effects were significantly larger than performing 1 or 2 additional VFs at the beginning and end of the observation. Conversely, a greater number of eyes was necessary in advanced stage than in moderate stage. In the 2-arm trial (80% probability of significance, and 1 eye per patient), the 80% probability of significance was observed with sample size = 80 eyes in each arm, a tendency that was similar to what observed for the 1-arm trial. Similar tendency was observed in the simulations with much slower VF progression (mean MD slope = -0.25 dB/year). Conclusions: The present study highlights the importance of considering disease stage when planning a clinical trial. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.