COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

本申请旨在证明奥尔巴尼 医学院眼科系作为一个 在拟议的多中心中建立一个有效和富有成效的临床中心 临床试验，标题为“协作初始青光眼治疗研究” （CIGTS）。 这项研究的目的是评估初始治疗是否 开角型青光眼是更有效的手段，阶梯式，中间 方案或通过手术方法。 奥尔巴尼医学院 临床中心将通过识别和 招募合格的患者，给予治疗方案， 由CIGTS协调中心分配，并在 研究的操作手册，跟踪和保留研究患者， 记录研究数据并将其传输至协调中心，以及 为提交CIGTS结果的报告做出贡献。作为 青光眼初始治疗合作研究的临床中心， 奥尔巴尼医学院青光眼科 狮子会眼科研究所眼科提供最先进的临床 青光眼的诊断和治疗的研究设施。 三 研究人员在青光眼研究方面有丰富的经验， 专门从事青光眼的大型咨询实践（大于15， 000青光眼患者就诊/年）。 此外，26个社区委员会 注册的眼科医生已经报名参加， 这个研究中心。 作为一个群体，他们提供了一个庞大的临床基地， 在纽约东北部（超过150，000例患者就诊/年） 最大化病人招募和护理。 在为期3个月的试验中， 本研究的招募使用手册中概述的标准 该中心确定了18名符合条件的患者， 有足够的患者招募潜力（附录1）。 这个中心 预计每月招募3名患者参与本研究。 研究人群将包括男女和各种疾病的患者。 与这一地理区域相一致的民族和种族背景 全国 详细介绍了我们的计划，以确定，招聘， 跟踪并留住这些患者，我们的意图是获得持续的高 关于治疗的视觉结果的质量数据，以及人员和 在我们的中心内提供的设施，以执行规定的 CIGTS的操作手册。

The intent of this application is to document the ability of the Albany Medical College, Department of Ophthalmology 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, medial regimen or by means of a surgical approach. The Albany Medical College'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 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. As a clinical center in the Collaborative Initial Glaucoma Treatment Study, the Glaucoma Service at the Albany Medical College, Department of Ophthalmology, Lions Eye Institute, offers a state of the art clinical research facility for the diagnosis and treatment of glaucoma. The three investigators have extensive experience in glaucoma research and have large consultative practices specializing in glaucoma ( greater than 15, 000 glaucoma patient visits /year) . In addition, 26 community board certified ophthalmologists have enrolled to actively participate with this center in the study. As a group, they offer a large clinical base in Northeastern New York ( greater than 150,000 patient visits/year) which maximizes patient recruitment and care. In a 3 month trial recruitment for this study using the criteria outlined in the Manual of Operations, this center identified 18 qualifying patients, representing adequate potential for patient recruitment (Appendix 1). This center expects to recruit 3 patients per month for participation in this study. The study population will include both sexes and patients of a variety of ethnic and racial backgrounds consistent with this geographical region of the country. 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.