Ocular Hypertension Treatment Study: Coordinating Center

描述(由申请人提供)：OHTS II队列研究的主要具体目标是确定是否存在延迟治疗高眼压症的惩罚。主要的具体目标将通过比较OHTS I中在OHTS II中开始治疗的原始观察参与者的POAG和不良事件的长期累积发生率与在整个OHTS I期间接受药物治疗并继续在OHTS II中治疗的药物参与者的长期累积发生率来进行测试。 协调中心的具体目标是通过以下方式提供全面的科学领导和业务支持，以实现OHTS II的主要和次要具体目标： 1.制定、分发和维护详细的程序手册 2.对临床工作人员进行OHTS II研究方案和程序的培训和认证 3.监测OHTS II方案的遵守情况，并向诊所工作人员和资源中心提供反馈 4.确保诊所和资源中心之间的合作 5.根据数据和安全监测委员会的要求，每半年监测一次药效和安全性 6.接收、编辑、存储和分析来自参与诊所、视野阅读中心、光盘阅读中心、共焦扫描激光眼底镜阅读中心和短波长视野计阅读中心的数据。 7.在编写专题介绍和出版物方面提供方法和统计方面的专门知识 8.制定有序结束研究的计划，包括参与者、诊所和资源中心 9.对研究数据进行归档和记录。

DESCRIPTION (provided by applicant): The primary specific aim of the OHTS II cohort study is to determine if there is a penalty for delaying treatment in ocular hypertension. The primary specific aim will be tested by comparing the long-term cumulative incidence of POAG and adverse events in the original observation participants in OHTS I who start treatment in OHTS II to the long-term cumulative incidence in medication participants who received medication throughout OHTS I and who continue treatment in OHTS II (Primary Specific Aim). The specific aim of the Coordinating Center is to provide overall scientific leadership and operational support to accomplish the primary and secondary specific aims of OHTS II by: 1. Developing, distributing and maintaining a detailed Manual of Procedures 2. Training and certifying clinical staff in OHTS II study protocol and procedures 3. Monitoring adherence to the OHTS II protocol and providing feedback to clinic staff and resource centers 4. Ensuring collaboration between clinics and resource centers 5. Monitoring efficacy and safety at semi-annual intervals and as requested by the Data and Safety Monitoring Committee 6. Receiving, editing, storing and analyzing data from participating clinics, Visual Field Reading Center, Optic Disc Reading Center, Confocal Scanning Laser Ophthalmoscope Reading Center and the Short Wave Length Perimetry Reading Center. 7. Providing methodological and statistical expertise in the preparation of presentations and publications 8. Developing plans for the orderly close-out of the study including participants, clinics, and resource centers 9. Archiving and documenting study data.