DATA COORDINATING CENTER FOR EARLY GLAUCOMA TRIAL

早期青光眼试验数据协调中心

• 批准号: 2164008
• 负责人: MCRISTINA LESKE
• 金额: $ 35.09万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-06-02 至 1998-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2164008
• 关键词: clinical trials; computer data analysis; computer program /software; cooperative study; data collection; data collection methodology /evaluation; early diagnosis; eye disorder chemotherapy; eye disorder diagnosis; glaucoma; glaucoma test; human subject; human therapy evaluation; information systems; intraocular pressure; optic disk; pathologic process; trabeculotomy; vision tests; visual fields

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.

早期显性青光眼试验（EMGT）是第一个大型随机， 对照临床试验，以评估降低 眼内压（IOP）对新检测到的 开角型青光眼 因此，这是一项极其重要的研究， 旨在解决眼科学中一个主要的未解决问题。 的 EMGT的主要目的是比较即刻治疗与 降低IOP（激光小梁成形术和倍他洛尔）与晚期或无 治疗新发现的开角型青光眼的进展，如 通过增加视野损失或视盘变化来测量。 的 主要目的将通过进行以下随机临床试验来实现： 300例患者将比较初始治疗的青光眼进展 与未经治疗的新检测到开角型青光眼患者相比。 这 比较将允许量化的影响，立即 在随访期间对进展进行降IOP治疗。 每三个月对患者进行一次随访，直到 青光眼进展终点至少4年。 二次 目的是：1）确定通过以下方法达到的IOP降低程度 治疗; 2）探索可能影响进展的因素;以及，3） 描述新发现的青光眼的自然史。 拟议的EMGT是一项合作努力，涉及临床 中心（CC）在马尔莫，瑞典，光盘摄影阅读中心在隆德 这两个数据中心都位于瑞典的隆德大学， 纽约大学，纽约州斯托尼布鲁克和国家眼科研究所。 该研究源于协调委员会编写的一项提案， 由瑞典医学研究理事会资助。 资金有限 200名患者的研究，只涉及CC。 本 协作涉及若干设计改变（例如，研究增加 把握度为70%-90%，样本量为300例患者，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），以加强原始研究 计划并加强对EMGT结果的解释。 DC将参与研究设计的所有方面， 实施和分析。 区议会的具体职责如下 1）作为EMGT的合作伙伴， 流行病学和生物统计输入到组织，设计， 试验的实施和分析; 2）合作开发和 分发表格、文件和议定书; 3）制定、执行和 维持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）编写研究报告 监测招募、数据收集、不良反应、 终点和数据质量; 7）协调和记录研究会议， 中心之间的沟通;和8）合作准备 公布结果。