Insights on Glaucoma from Analysis of the CIGTS Data

描述（由申请人提供）：由国家眼科研究所支持的多中心临床试验，对新诊断的开角型青光眼（OAG）应该如何治疗提供了独特的见解，无论是最初的手术治疗还是药物干预。尽管如此，许多与青光眼及其治疗相关的重要临床信息仍需在广泛的CIGTS数据资源中进行评估。本资助申请中所描述的拟议数据分析的实施将为研究与开角型青光眼患者的管理和护理直接相关的其他研究问题提供独特的、具有成本效益的机会。我们建议进行广泛的分析，以解决以下四个具体目标：(1)建立一个预测模型，提供在治疗OAG期间影响视野（VF）改善的因素排名。(2)描述未治疗的开角型青光眼（OAG）的自然发展历史，并建立此类眼睛OAG发病的预测模型。(3)调查CIGTS中记录的VF缺陷，包括其位置、簇数、基线时的程度、IOP降低和升高的反应，以及基线VF缺陷特征与进行性VF丧失概率的关系。(4)比较定义和分析渐进性视野丧失的不同方法——逐点线性回归、混合线性回归、“基于事件”的方法和轨迹分析——以及它们产生的结果（风险因素、VF进展的估计）。

DESCRIPTION (provided by applicant): The Collaborative Initial Glaucoma Treatment Study (CIGTS), a National Eye Institute supported multicenter clinical trial, provided unique insights to how newly diagnosed open-angle glaucoma (OAG) should be treated, whether by initial surgical or medical intervention. Even so, much clinically-relevant and important information to glaucoma and its treatment remains to be evaluated in the extensive CIGTS data resource. Conduct of the proposed data analyses described in this grant application will provide unique, cost-effective opportunities to investigate additional research questions that are directly relevant to the management and care of patients who have open-angle glaucoma. We propose to conduct extensive analyses that address the following four specific aims: (1) Develop a predictive model that provides a ranking of factors that influence improvement in visual field (VF) during treatment of OAG. (2) Describe the natural history of open-angle glaucoma (OAG) development in initially un-treated fellow eyes, and develop a predictive model for the onset of OAG in such eyes. (3) Investigate VF defects documented in the CIGTS, including their location, cluster number, and extent at baseline, response to IOP reduction and elevation, and the association of baseline VF defect characteristics with the probability of progressive VF loss. (4) Compare alternate methods to define and analyze progressive loss of visual field - pointwise linear regression, mixed linear regression, "event-based" methods, and trajectory analysis - with regard to the outcomes they yield (risk factors, estimates of VF progression). PUBLIC HEALTH RELEVANCE: The Collaborative Initial Glaucoma Treatment Study, a National Eye Institute supported multicenter clinical trial, provided unique insights to how newly diagnosed glaucoma should be treated, whether by initial surgical or medical intervention. Conduct of the proposed data analyses described in this grant application will expand our ability to provide evidence-based direction to the management and care of patients diagnosed with glaucoma. In addition, these analyses will inform future studies of how best to evaluate progression of visual field loss in glaucoma, which is the most important outcome to monitor in studies of glaucoma treatment.