ARGON LASER TRABECULOPLASTY CLINICAL TRIAL

本方案是开展多中心随机临床试验的方案。 这项试验旨在评估激光小梁成形术的疗效 开角型青光眼标准药物治疗的替代方案。这场审判 将涉及招募240名新诊断为 对称性开角型青光眼。30岁以上的患者患有 眼压大于或等于27毫米汞柱和视神经的证据 双眼受损将有资格参加登记。病人将会是 跟踪调查了至少两年，以便收集关于 试验过程中的压力水平，并提供比较 视野损失率和视神经拔罐增加的数据。 治疗组将在两年结束时进行以下方面的比较 所需的医疗量来控制眼内 压力和/或控制青光眼神经损害。需要激光照射的眼睛 将被随机选择。这一过程将包括96次烧伤 输送到小梁网的前部着色部分， 避开网眼后部和巩膜骨刺。烧伤的人 将以足够的强度输送，以使 在气泡形成的临界点(700-1200 mW)形成网状结构。这个 另一只眼睛将被分配到内科治疗并放置在单眼 局部用药。需要额外治疗的眼睛 最初的治疗将在随后的局部药物治疗中添加 根据协议循序渐进的方式。这场审判将涉及6名 临床中心，数据协调中心，光盘立体照相阅读 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.