COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY

合作性初始青光眼治疗研究

• 批准号: 2444333
• 负责人: Ronald Leon Gross
• 金额: $ 6.61万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-07-01 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2444333
• 关键词: clinical trials; cooperative study; eye disorder chemotherapy; eye laser surgery; eye pharmacology; glaucoma; glaucoma surgery; health surveys; human subject; human therapy evaluation; intraocular pressure; ocular hypotensive; quality of life; trabeculotomy; vision; vision tests; visual fields; visual perception

The intent of this application is to document the ability of the Department of Ophthalmology, Baylor College of Medicine, to participate as an effective and productive clinical center in the proposed multi- center 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. Baylor College of Medicine'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. This application describes the ability of Baylor College of Medicine's Clinical Center to enroll approximately 24 patients per year, based on pilot studies of patient eligibility conducted during a three-month period. 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.

此应用程序的目的是记录 贝勒医学院眼科科学系 作为拟议中的有效且富有生产力的临床中心 中心临床试验标题为“协作初始青光眼 治疗研究（CIGTS）”。本研究的目的是评估是否是否 开放角度青光眼的初始治疗方法更有效 踩踏医疗方案或通过手术方法。 贝勒 医学院的临床中心将参加CIGTS 识别和招募合格的患者，管理 CIGTS协调中心分配的治疗方案和 在研究手册中定义的操作手册，遵循和 保留研究患者，将研究数据记录和转移到 协调中心，并为将提出的报告做出贡献 CIGTS结果。 该申请描述了贝勒医学院的能力 基于 三个月内进行的患者资格的试点研究 时期。 提供了我们计划识别，招募，关注的计划的详细信息 并保留这些患者，我们的意图是获得一贯的高 有关治疗视觉结果的质量数据，人员和人员 我们中心内可用的设施来执行 CIGTS的操作手册。