COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

这项申请的目的是记录纽约的能力 眼耳医院作为一家有效和富有成效的医院参与 临床中心在拟议的多中心临床试验中，题为 “协作性青光眼初始治疗研究”(CIGTS)。这项研究是 目的是评价开角型青光眼的初始治疗是否 更有效的方式是采用阶梯式的医疗方案或通过 手术方式。纽约眼耳医院临床中心 将通过确定和招募符合条件的人员参与CIGTS 患者，按照CIGTS分配的治疗方案进行治疗 协调中心和《研究手册》中的定义 手术，跟踪和保留研究患者，记录和 将研究数据传输到协调中心，并为 将呈现CIGTS结果的报告。 卫星分中心将招募更多的患者 总部设在长岛犹太人医疗中心。该中心将在 从当地眼科医生那里招募新兵。它的整体功能， 协调、管理和后续行动将由纽约办事处监督 眼耳医院临床中心。 这个应用程序描述了纽约眼和耳的能力 医务室临床中心每年招收约50名患者， 基于在3个月内对患者资格进行的试点研究 句号。卫星分中心预计将招收约15至 每年20个病人。我们提供了详细的计划，以确定， 招募、跟踪和留住这些患者，我们的意图是获得 关于治疗结果的持续高质量数据，以及 我们中心内可用来执行任务的人员和设施 CIGTS《操作手册》的规定。

The intent of this application is to document the ability of The New York Eye and Ear Infirmary to participate as an effective and productive Clinical Center in the proposed multicenter clinical trial, entitled "Collaborative Initial Glaucoma Treatment Study" (CIGTS). This study's purpose is to evaluate whether initial treatment of open-angle glaucoma is more effective by means of a stepped, medical regimen or by means of a surgical approach. The New York Eye and Ear Infirmary's Clinical Center will participate in the CIGTS by identifying and recruiting eligible patients, administering the treatment regimen as assigned by the CIGTS's Coordinating Center and as defined within the study's Manual of Operations, following and retaining study patients, recording and transferring study data to the Coordinating Center, and contributing to reports that will present the CIGTS results. Additional patients will be recruited by a Satellite Subcenter headquartered at Long Island Jewish Medical Center. This Center will in turn recruit from local ophthalmologists. Its overall functioning, coordination, management and follow-up will be supervised by The New York Eye and Ear Infirmary Clinical Center. This application describes the ability of The New York Eye and Ear Infirmary's Clinical Center to enroll approximately 50 patients per year, based upon pilot studies of patient eligibility conducted during a 3 month period. The Satellite Subcenter is expected to enroll approximately 15 to 20 patients per year. Details are provided of our plans to identify, recruit, follow, and retain these patients, our intent to obtain consistently high quality data on the visual outcomes of treatment, and the personnel and facilities available within our center to carry out the provisions of the CIGTS's Manual of Operations.