OCULAR HYPERTENSION TREATMENT STUDY

青光眼是美国导致失明的主要原因之一， 其他工业化国家。事实上，青光眼现在被认为是 非洲裔美国人失明的头号原因。高架 眼压(IOP)是一种常见的疾病，被认为是 开角型青光眼发生的主要危险因素。的确有 关于早期药物治疗是否有效的相互矛盾的证据 预防或延缓青光眼损害的发病 眼压升高(称为高眼压 个人或青光眼可疑患者)。拟议的研究是一项长期的、 随机、多中心、单盲临床试验，以确定 药物降低眼压可预防或延迟黄斑变性的发生 高眼压患者青光眼视神经和/或视野损害 研究对象。1500名眼压大于或等于24毫米汞柱的受试者 至少一只眼(眼压大于或等于32毫米汞柱) 相当于同眼21 mm HG)由连续两次测定 测量间隔至少2小时，但不超过12周 双眼的正常视野和视盘将随机分配 接受双眼阶梯式治疗或密切观察 只对两只眼睛都有效。由于眼压的这种水平， 受试者被认为处于中度风险的开放发展- 房角青光眼。受试者将被自动跟踪，每年两次， 阈值、中央、静态视野检查(Humphrey Program 30-2)和一次 每年都有立体视盘照片。研究的终点是 进行性视盘损害和/或可复制的青光眼视野 患者的两只眼睛都失去了。所有视野和视盘 照片将在阅读中心以蒙面方式阅读。 虽然这项试验旨在研究早期治疗的有效性和安全性 药物治疗高眼压，还会有其他好处 井。这项研究将使我们能够改进和验证风险估计 适用于全国大样本的个体高眼压患者。 此外，这项研究还将确定非洲的转换率。 美国人患上开角型青光眼的高眼压。在 本研究的结论是，从业者应该能够做出合理的 估计个体高眼压患者的风险，并确定 哪些高眼压患者最有可能受益于早期 预防性医疗。 研究主席办公室和数据协调中心将在 华盛顿大学。视野阅读中心将设在加州大学。 戴维斯和耶鲁大学的光盘阅读中心。各种不同的 临床中心将由NEI使用RFA机制在 以后再说。

Glaucoma is one of the leading causes of blindness in the United States and other industrialized countries. In fact, glaucoma is now recognized to be the number one cause of blindness in African Americans. Elevated intraocular pressure (IOP) is a common condition and is thought to be the leading risk factor for the development of open-angle glaucoma. There is conflicting evidence as to whether early medical treatment is effective in preventing or delaying the onset of glaucomatous damage in individuals with elevated intraocular pressure (referred to as ocular hypertensive individuals or glaucoma suspects). The proposed study is a long-term, randomized, multicenter, single-masked clinical trial to determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous optic nerve and/or visual field damage in ocular hypertensive subjects. 1,500 subjects with IOP's greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye (IOP's greater than or equal to 21 mm HG in the fellow eye) as determined by two consecutive measurements at least 2 hours, but not greater than 12 weeks, apart and normal visual fields and optic discs in both eyes will be assigned randomly to receive stepped medical treatment to both eyes or to close observation only to both eyes. Because of this level of intraocular pressure, the subjects are considered to be at moderate risk for the development of open- angle glaucoma. The subjects will be followed twice yearly with automated, threshold, central, static perimetry (Humphrey program 30-2) and once yearly with stereoscopic optic disc photographs. The study endpoints are progressive optic disc damage and/or reproducible glaucomatous visual field loss in either eye of a patient. All visual fields and optic disc photographs will be read in masked fashion in Reading Centers. While this trial is designed to study the efficacy and safety of early medical treatment in ocular hypertension, there will be other benefits as well. This study will allow us to refine and validate estimates of risk for individual ocular hypertensive patients in a large national sample. Furthermore, this study will also determine the conversion rate of African American ocular hypertensive subjects to open-angle glaucoma. At the conclusion of this study, practitioners should be able to make reasonable estimates of risk for individual ocular hypertensive patients and determine which ocular hypertensive individuals are most likely to benefit from early prophylactic medical treatment. The Study Chairman's Office and the Data Coordinating Center will be at Washington University. The Visual Field Reading Center will be at U.C.- Davis and the Optic Disc Reading Center at Yale University. The various Clinical Centers will be chosen by the NEI using an RFA mechanism at a later time.