Trial reportAmerican journal of ophthalmology2019
Assessment of the Impact of an Endpoint Committee in the Ocular Hypertension Treatment Study.
Trial report in American journal of ophthalmology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000125 (Ocular Hypertension Treatment Study), which is not on this map. Cited by 10 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.
Ocular Hypertension Treatment Study (OHTS)
Who cites it
10 citing papers in PubMed, 20 citations in OpenAlex.
- Risk Calculation in the Medication Arm of the Ocular Hypertension Treatment Study.Ophthalmology. GlaucomaTrial
- Deep Learning Identifies High-Quality Fundus Photographs and Increases Accuracy in Automated Primary Open Angle Glaucoma Detection.Translational vision science & technology · 2024Article
- One-Vote Veto: Semi-Supervised Learning for Low-Shot Glaucoma Diagnosis.IEEE transactions on medical imaging · 2023Article
- A potential primary endpoint for clinical trials in glaucoma neuroprotection.Scientific reports · 2023Article
- Detecting Glaucoma from Fundus Photographs Using Deep Learning without Convolutions: Transformer for Improved Generalization.Ophthalmology science · 2023Article
- Rationale and Development of an OCT-Based Method for Detection of Glaucomatous Optic Neuropathy.Journal of glaucoma · 2022Article
- Glaucoma Suspects: The Impact of Risk Factor-Driven Review Periods on Clinical Load, Diagnoses, and Healthcare Costs.Translational vision science & technology · 2022Article
- Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up.JAMA ophthalmology · 2021Article
- Evaluation of a Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data: A Secondary Analysis of 2 Randomized Clinical Trials.JAMA ophthalmology · 2020Article
- The 24-2 Visual Field Guided Progression Analysis Can Miss the Progression of Glaucomatous Damage of the Macula Seen Using OCT.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
10 authors at 4 institutions in 1 country.
Funding
Abstract
purposeTo assess the impact of a masked Endpoint Committee on estimates of the incidence of primary open-angle glaucoma (POAG) treatment efficacy and statistical power of the Ocular Hypertension Treatment Study-Phase 1, 1994-2002 (OHTS-1).
designRetrospective interrater reliability analysis of endpoint attribution by the Endpoint Committee.
methodsAfter study closeout, we recalculated estimates of endpoint incidence, treatment efficacy, and statistical power using all-cause endpoints and POAG endpoints. To avoid bias, only the first endpoint per participant is included in this report.
resultsThe Endpoint Committee reviewed 267 first endpoints from 1636 participants. The Endpoint Committee attributed 58% (155 of 267) of the endpoints to POAG. The incidence of all-cause endpoints vs POAG endpoints was 19.5% and 13.2%, respectively, in the observation group and 13.1% and 5.8%, respectively, in the medication group. Treatment effect for all-cause endpoints was a 33% reduction in risk (relative risk = 0.67, 95% confidence interval [CI] of 0.54-0.84) and a 56% reduction in risk for POAG endpoints (relative risk = 0.44, 95% CI of 0.31-0.61). Post hoc statistical power for detecting treatment effect was 0.94 for all-cause endpoints and 0.99 for POAG endpoints.
conclusionEndpoint Committee adjudication of endpoints improved POAG incidence estimates, increased statistical power, and increased calculated treatment effect by 23%. An Endpoint Committee should be considered in therapeutic trials when common ocular and systemic comorbidities, other than the target condition, could compromise study results.
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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.