机构：[1]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK[2]Division of Optometry and Visual Science, School of Health Sciences, City, University of London, UK[3]School of Computer Science and Engineering, Beihang University, Beijing, China
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摘要：
To evaluate the ability of various visual field (VF) analysis methods to discriminate treatment groups in glaucoma clinical trials and establish the value of time-domain optical coherence tomography (TD OCT) imaging as an additional outcome.VFs and retinal nerve fibre layer thickness (RNFLT) measurements (acquired by TD OCT) from 373 glaucoma patients in the UK Glaucoma Treatment Study (UKGTS) at up to 11 scheduled visits over a 2 year interval formed the cohort to assess the sensitivity of progression analysis methods. Specificity was assessed in 78 glaucoma patients with up to 11 repeated VF and OCT RNFLT measurements over a 3 month interval. Growth curve models assessed the difference in VF and RNFLT rate of change between treatment groups. Incident progression was identified by 3 VF-based methods: Guided Progression Analysis (GPA), 'ANSWERS' and 'PoPLR', and one based on VFs and RNFLT: 'sANSWERS'. Sensitivity, specificity and discrimination between treatment groups were evaluated.The rate of VF change was significantly faster in the placebo, compared to active treatment, group (-0.29 vs +0.03 dB/year, P<.001); the rate of RNFLT change was not different (-1.7 vs -1.1 dB/year, P=.14). After 18 months and at 95% specificity, the sensitivity of ANSWERS and PoPLR was similar (35%); sANSWERS achieved a sensitivity of 70%. GPA, ANSWERS and PoPLR discriminated treatment groups with similar statistical significance; sANSWERS did not discriminate treatment groups.Although the VF progression-detection method including VF and RNFLT measurements is more sensitive, it does not improve discrimination between treatment arms.
基金：
The sponsor for both the UKGTS and RAPID data collection was Moorfields Eye Hospital NHS Foundation Trust. The Sponsor was responsible for ensuring the IRB approval and NHS Permissions were in place before the initiation of the studies and research governance. The Sponsor is the employer of two statisticians contributing to the analysis of the data (AQ and PP), but had no influence on the choice of analysis or interpretation of the data.
The principal funding for this work was the United Kingdom’s National Institute for Health Research Health Technology Assessment (HTA) Project Funding: 11/129/245 - Assessing the Effectiveness of Imaging Technology to Rapidly Detect Disease Progression in Glaucoma. Additional unrestricted funding was obtained from Pfizer Inc to support the statistical analyses.
Funding for the UKGTS was through an unrestricted investigator-initiated research grant from Pfizer, with supplementary funding from the UK’s NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK. Equipment loans were made by Heidelberg Engineering, Carl Zeiss Meditec and Optovue (Optovue, Fremont, CA, USA).
DFG-H, AQ, PP and HZ are partly funded by the NIHR Biomedical Research Centre based at Moorfields Eye Hospital and UCL Institute of Ophthalmology.
DFG-H’s chair at UCL is supported by funding from the International Glaucoma Association.
The views expressed are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health.
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外文
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第一作者：
第一作者机构：[1]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK[*1]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
通讯作者：
通讯机构：[1]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK[*1]NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK
推荐引用方式(GB/T 7714)：
Garway-Heath David F,Quartilho Ana,Prah Philip,et al.Evaluation of Visual Field and Imaging Outcomes for Glaucoma Clinical Trials (An American Ophthalomological Society Thesis).[J].Transactions of the American Ophthalmological Society.2017,115:T4.
APA：
Garway-Heath David F,Quartilho Ana,Prah Philip,Crabb David P,Cheng Qian&Zhu Haogang.(2017).Evaluation of Visual Field and Imaging Outcomes for Glaucoma Clinical Trials (An American Ophthalomological Society Thesis)..Transactions of the American Ophthalmological Society,115,
MLA：
Garway-Heath David F,et al."Evaluation of Visual Field and Imaging Outcomes for Glaucoma Clinical Trials (An American Ophthalomological Society Thesis).".Transactions of the American Ophthalmological Society 115.(2017):T4
