COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

本申请旨在证明纽约酒店 眼耳医院作为一个有效和富有成效的 在拟定的多中心临床试验中， “青光眼初始治疗合作研究”（CIGTS）。 这项研究的 目的是评估开角型青光眼的初始治疗是否 更有效的方法，通过一个阶梯，医疗方案或通过一个 手术入路 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加CIGTS 患者，给予CIGTS分配的治疗方案 协调中心和研究手册中的定义 手术、随访和保留研究患者、记录和 将研究数据传输至协调中心，并协助 报告将介绍CIGTS的结果。 卫星分中心将招募更多患者 长岛犹太医疗中心Long Island Jewish Medical Center 该中心将在 从当地眼科医生中招募。 它的总体运作， 协调、管理和后续行动将由纽约 眼耳医院临床中心。 此应用程序描述了纽约眼耳的能力 医务室的临床中心每年招募大约50名患者， 基于3个月期间进行的患者合格性试点研究， 期卫星分中心预计将招收约15至 每年20名患者。 我们的计划提供了细节，以确定， 招募、跟踪和留住这些患者，我们的目的是获得 关于治疗视力结果的持续高质量数据，以及 我们中心内的人员和设施，以执行 《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.