ARGON LASER TRABECULOPLASTY CLINICAL TRIAL

本提案是一项多中心随机临床试验的计划， 试验，旨在评估氩激光小梁成形术作为 开角型青光眼的标准药物治疗的替代方法。 审判 将招募240名新诊断的 对称性开角型青光眼 年龄超过30岁的患者， 眼内压27 mm Hg或更高且存在视神经迹象 两只眼睛都有损伤才有资格入组。 患者将 至少跟踪两年，以收集以下信息 压力水平，并提供比较 视野丧失率和视神经杯状增加的数据。 治疗组将在两年结束时进行比较， 控制眼内出血所需的药物治疗量 压迫和/或控制昏迷性神经损伤。 要用激光治疗的眼睛 将被随机挑选。 整个过程将包括96次烧伤 递送到小梁网的前色素部分， 避开网状物的后部和巩膜突。 烧伤 将以足以引起 刚好在气泡形成的阈值（700-1200 mW）处的网状结构。 的 另一只眼睛将被分配到药物治疗，并放置在一个单一的 局部用药 眼睛需要额外的治疗 最初的治疗将有随后的局部药物添加在一个 根据协议逐步方式。 审判将涉及6名 临床中心，数据协调中心，光盘立体照片阅读 中心和视野阅读中心。

This proposal is a plan for carrying out a multicenter randomized clinical trial, designed to assess the efficacy of argon laser trabeculoplasty as an alternative to standard medical therapy of open angle glaucoma. The trial will involve the recruitment of 240 patients with newly diagnosed symmetrical open-angle glaucoma. Patients over the age of 30 years with intraocular pressures of 27 mm Hg or greater and evidence of optic nerve damage in both eyes will be eligible for enrollment. Patients will be followed for a minimum of two years in order to collect information on pressure levels over the course of the trial and to provide comparative data on the rate of visual field loss and increased optic nerve cupping. Treatment groups will be compared at the end of the two years with regard to the amount of medical treatment needed to control the intraocular pressure and/or control glaucomatous nerve damage. The eye to be lasered will be randomly selected. The procedure will consist of 96 burns delivered to the anterior pigmented portion of the trabecular meshwork, avoiding the posterior portion of the meshwork and scleral spur. The burns will be delivered at an intensity sufficient to cause blanching of the meshwork just at the threshold of bubble formation (700-1200 mW). The fellow eye will be assigned to medical therapy and placed on a single topical medication. Eyes requiring added treatment over and above the initial treatment will have subsequent topical medication added in a step-wise fashion according to a protocol. The trial will involve 6 clinical centers, a data coordinating center, a disc stereophoto reading center, and visual field reading center.