Ocular hypertension treatment study (OHTS)

描述（由申请人提供）：既然OHTS I已经证明局部眼部消肿药物在降低中度和高度风险高眼压患者的开角型青光眼发生率方面是安全有效的，那么确定何时开始治疗高眼压症是很重要的。OHTS II的主要具体目的是确定延迟高眼压治疗是否会受到惩罚。将通过比较OHTS I中开始OHTS II治疗的原始观察受试者的POAG和不良事件的长期累积发生率与在OHTS I期间接受药物治疗并在OHTS II中继续治疗的药物治疗受试者的长期累积发生率来检验主要特定目的（主要特定目的）次要目的为： 1.提高OHTS I中开发的风险模型的精确度和完整性，以预测哪些高眼压受试者将发展为POAG。 2.目的探讨阈下视野和视盘改变对原发性开角型青光眼（POAG）预后的预测价值。 3.确定治疗保护是否存在种族差异。 参与者每年两次进行自动阈值，中心静态视野检查（Humphrey 30-2），每年一次立体视盘照片。研究终点是可归因于POAG的可再现的视神经退化和/或可再现的视野异常。我们预计OHTS I的1，375名积极参与者中有90%将参加OHTS II。将对受试者进行至少5年的随访，随访持续至数据和安全性监查委员会确定的研究终止。与OHTS I一样，研究主席办公室和协调中心位于华盛顿大学圣路易斯分校。视野阅读中心位于加州大学戴维斯分校，萨克拉门托，加利福尼亚州，视神经盘阅读中心位于迈阿密佛罗里达州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均已获得OHTS II的当地IRB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.