Ocular hypertension treatment study (OHTS)

描述(由申请人提供)：既然OHTS I已经证明，局部降压药物在降低中、高风险高眼压患者开角型青光眼发病率方面是安全和有效的，因此确定何时应该开始治疗高眼压非常重要。OHTS II的主要具体目标是确定是否存在对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，以及在整个OHTS I期间接受药物治疗并在OHTS II(主要特定目标)中继续治疗的药物参与者的长期累积发生率来进行测试。次要目标是： 1.为了提高OHTS I中建立的预测哪些高眼压参与者将发生POAG的风险模型的精确度和完整性。 2.确定阈值下视野和视盘改变的预测准确性，为POAG的后续发展提供依据。 3.确定在待遇保护方面是否存在种族差异。 参与者每年接受两次自动阈值、中央静态视野检查(Humphrey 30-2)和一次立体视盘照片的跟踪检查。研究终点是可归因于POAG的可复制的视神经恶化和/或可复制的视野异常。我们预计1,375名OHTS I的活跃参与者中有90%将参加OHTS II。参与者将被跟踪至少5年，并继续跟踪，直到数据和安全监测委员会确定研究终止。与OHTS I一样，研究主席办公室和协调中心设在密苏里州圣路易斯的华盛顿大学。视野阅读中心位于加利福尼亚州萨克拉门托的加州大学戴维斯分校，而光盘阅读中心位于佛罗里达州迈阿密的巴斯科姆·帕尔默眼科研究所。临床中心与OHTS I相同。 OHTS II的议定书已得到执行/指导委员会和全面调查小组的批准。所有临床中心和资源中心都已获得当地IRB对OHTS II的批准。

DESCRIPTION (provided by applicant): Now that OHTS I has shown that topical ocular hypotensive medication is safe and effective in reducing the incidence of open angle glaucoma in moderate and high risk ocular hypertensive patients, it is important to determine when treatment should be initiated in ocular hypertension. The primary specific aim of OHTS II 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) Secondary aims are: 1. To increase the precision and completeness of the risk model developed in OHTS I to predict which ocular hypertensive participants will develop POAG. 2. To determine the predictive accuracy of subthreshold visual field and optic disc changes for subsequent development of POAG. 3. To determine if there is a racial difference in treatment protection. Participants are followed twice yearly with automated threshold, central static perimetry (Humphrey 30-2) and once yearly with stereoscopic optic disc photographs. The study endpoints are reproducible optic nerve deterioration and/or reproducible visual field abnormalities attributable to POAG. We expect 90% of the 1,375 active participants in OHTS I to enroll in OHTS II. Participants will be followed for a minimum of 5 years with follow-up continuing until study termination as determined by the Data and Safety Monitoring Committee. As in OHTS I, the Study Chairman's Office and the Coordinating Center are at Washington University, St. Louis, MO. The Visual Field Reading Center is at University of California-Davis, Sacramento, CA, and the Optic Disc Reading Center is at Bascom Palmer Eye Institute, Miami FL. Clinical Centers are the same as in OHTS I. The protocol for OHTS II has been approved by the Executive/Steering Committee and the Full Investigative Group. All Clinical Centers and Resource Centers have received local IRB approval for OHTS II.