DATA COORDINATING CENTER FOR EARLY GLAUCOMA TRIAL

早期显性青光眼试验(EMGT)是第一个大规模随机、 临床对照试验评价降脂降压的效果 眼压(IOP)对新近发现的青光眼进展的影响 开角型青光眼。因此，这是一项极其重要的研究 旨在解决眼科一个重大悬而未决的问题。这个 EMGT的主要目的是比较即时治疗和 降低眼压(激光小梁成形术和倍他洛尔)与延迟或不治疗相比 对新发现的开角型青光眼进展的治疗，AS 通过增加视野损失或视盘改变来测量。这个 主要目标将通过进行一项随机临床试验来实现 300名患者将比较最初治疗中青光眼的进展情况 与新发现的开角型青光眼未经治疗的患者进行比较。这 比较将允许量化即时的影响 随访期降压治疗对病情进展的影响。 患者将每三个月进行一次跟踪，直到出现 青光眼进展终点至少四年。次要的 目标是：1)确定以下各项所达到的眼压降低程度 治疗；2)探索可能影响病情进展的因素；3) 描述新发现的青光眼的自然病史。 拟议的EMGT是一项合作努力，涉及临床 瑞典马尔默的光盘摄影阅读中心(CC)，隆德的光盘摄影阅读中心 两人都在瑞典隆德大学，在国家数据中心(DC) 纽约大学石溪分校和国家眼科研究所。 这项研究源于CC准备的一份提案，该提案已获批准 并由瑞典医学研究委员会资助。资金有限 一项有200名患者参加的研究，只涉及CC。现在 协作涉及几个设计更改(例如，增加研究 功率从70%到90%，样本大小为300名患者，纳入 严格的临床试验方法，包括独立的DC和 数据安全和监测委员会)加强原创研究 计划并加强对EMGT结果的解释。 DC将参与研究设计的各个方面， 实施和分析。区议会的具体职责如下 要：1)作为EMGT的协作合作伙伴，并提供 流行病学和生物统计学对组织的投入、设计、 进行和分析试验；2)合作开发和 分发表格、文件和协议；3)制定、实施和 维护研究所有方面的质量保证程序；4) 制定和监督随机化过程；5)负责数据 管理、处理和分析；6)准备研究报告 监督招募、数据收集、不良影响、 终端和数据质量；7)协调和记录研究会议和 中心之间的沟通；以及8)合作准备 结果的公布。

The Early Manifest Glaucoma Trial (EMGT) is the first large randomized, controlled clinical trial to evaluate the effect of lowering the intraocular pressure (IOP) on the progression of newly detected open-angle glaucoma. As such, it is an extremely important study designed to address a major unresolved issue in ophthalmology. The primary aim of the EMGT is to compare the effect of immediate therapy to lower the IOP (laser trabeculoplasty and betaxolol) versus late or no treatment on the progression of newly detected open-angle glaucoma, as measured by increasing visual field loss or optic disc changes. The primary aim will be achieved by conducting a randomized clinical trial of 300 patients that will compare glaucoma progression in initially treated vs untreated patients with newly detected open-angle glaucoma. This comparison will allow quantification of the effect of immediate IOP-lowering treatment on progression during the followup period. Patients will be followed every three months until the development of glaucoma progression endpoints for a minimum of four years. Secondary aims are to: 1) determine the extent of IOP reduction attained by treatment; 2) explore the factors that may Influence progression; and, 3) describe the natural history of newly detected glaucoma. The proposed EMGT is a collaborative effort that involves a Clinical Center (CC) in Malmo, Sweden, a Disc Photography Reading Center in Lund both at the University of Lund, Sweden, a Data Center (DC) at the State University of New York, Stony Brook, NY and the National Eye Institute. The study originated from a proposal prepared by the CC that was approved and funded by the Swedish Medical Research Council. Funding was limited to a study of 200 patients and involved only the CC. The present collaboration involves several design changes (e.g., increase in study power from 70% to 90% and sample size to 300 patients, incorporation of rigorous clinical trial methodology, inclusion of an independent DC and a Data Safety and Monitoring Committee) to strengthen the original study plan and enhance interpretation of EMGT results. The DC will be involved in all aspects of the study design, implementation and analysis. The specific responsibilities of the DC are to: 1) serve as a collaborating partner in the EMGT and provide epidemiologic and biostatistical input to the organization, design, conduct and analysis of the trial; 2) collaborate in the development and distribution of forms, documents and protocols; 3) develop, implement and maintain quality assurance procedures for all aspects of the study; 4) develop and monitor the randomization process; 5) be responsible for data management, processing and analysis; 6) prepare reports for study committees to monitor recruitment, data collection, adverse effects, endpoints and data quality; 7) coordinate and document study meetings and communications between centers; and 8) collaborate in preparing publications of the results.