ARGON LASER TRABECULOPLASTY/CLINICAL TRIAL

氩激光小梁成形术/临床试验

• 批准号: 3551328
• 负责人: JOSEPH KRUG
• 金额: $ 4.2万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 1983
• 资助国家: 美国
• 起止时间: 1983-02-01 至 1990-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3551328
• 关键词: cooperative study; disease /disorder prevention /control; eye laser surgery; glaucoma; glaucoma surgery; glaucoma test; human subject; human therapy evaluation; intraocular pressure; longitudinal human study; ocular hypotensive; trabecular meshwork

This proposal is a plan for carrying out a multicenter randomized clinical trial designed to assess the efficacy of argon laser trabeculoplasty (ALT) 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. Only patients aged 30 or older (of either sex) with intraocular pressures of 27 mm. Hg. or greater, and evidence of optic nerve damage in both eyes will be eligible for enrollment. The patients will each 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 vision 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 ALT will consist of 96 burns delivered onto the anterior middle aspect of the trabecular meshwork, avoiding the posterior or uveal meshwork. The burns will be delivered at a suitable intensity of cause blanching of the meshwork just at the threshold of bubble formation (between 700 and 1200 MW per lesion). The fellow eye assigned to medical therapy will be placed on a single topical medication. Eyes requiring added treatment over and above the initial treatment (i.e., laser trabeculoplasty or single topical medication) will have subsequent topical medication(s) added in a step fashion according to a protocol. The trial will involve a total of 6 Clinical Centers, a Data Coordinating Center, a Disc Stereo Photo Reading Center, and a Visual Field Reading Center.

该建议是执行多中心随机临床的计划 旨在评估氩激光小梁成形术（ALT）的功效的试验 作为开放角度青光眼标准药物治疗的替代方法。 这 试验将涉及240名新诊断患者的招募 对称的开角青光眼。 只有30岁或以上的患者（任何一个 性别），眼内压力为27毫米。 HG。或更大，以及证据 两只眼睛的视神经损伤都有资格参加。 这 每个患者将至少遵循两年 在试验过程中收集有关压力水平的信息， 提供有关视野损失率和增加的比较数据 视神经拔罐。 将在治疗组的结尾进行比较 关于控制所需的医疗数量的两年 眼内压和/或对照的青光眼神经损伤。 眼睛 要激光将随机选择。 ALT将由96个燃烧组成 递送到小梁网的前方方面 避免后部或卵子网格。 烧伤将在 仅在阈值处的网格工程的合适原因强度 气泡形成（每个病变之间的700至1200兆瓦）。 同伴的眼睛 分配给医疗疗法的一种局部药物将被放置。 眼睛需要在初始治疗之外添加治疗的眼睛（即 激光小梁成形术或单局部用药）随后将有 根据协议，局部用药以步骤添加。 这 试验将涉及总共6个临床中心，这是一个数据协调 中心，盘式立体照片阅读中心和视野阅读 中心。