ARGON LASER TRABECULOPLASTY CLINICAL TRIAL

本提案是一项多中心随机临床试验的计划， 分配用于评估氩激光小梁成形术（ALT）疗效的试验 作为开角型青光眼标准药物治疗的替代。 的 试验将招募240名新诊断的 对称性开角型青光眼。 仅30岁或以上的患者（ 眼内压27 mm Hg或更高，并且有证据表明 双眼视神经损伤将有资格入组。 的 每例患者将接受至少两年的随访， 在试验过程中收集压力水平信息， 提供关于视野丧失率的比较数据， 视神经拔罐 治疗组将在研究结束时进行比较。 两年的后续治疗量 需要控制眼内压，并确定有效性 防止进一步的神经损伤 如果ALT等于或优于 医学，将努力继续，并可能扩大， 研究了五年以上，以跟踪视神经的状态，在这两个 一群眼睛。 随机选择接受激光治疗的眼睛。 的ALT 将由96个烧伤组成，这些烧伤被输送到 小梁网，避开后部或葡萄膜网。 烧伤 将以适当的强度输送，以使 刚好在气泡形成的阈值处的网状结构（在700和1200 MW之间 每个病变）。 分配接受药物治疗的对侧眼将置于 一种局部用药 需要额外治疗的眼睛 初始处理（即，激光小梁成形术或单次局部 药物）以控制IOP，随后将添加局部药物， 根据协议的逐步方式。 审判将涉及 6个临床中心，一个数据协调中心，一个光盘立体照片 阅读中心和视野阅读中心。

This proposal is a plan for carrying out a multicenter randomized clinical trial assigned 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 of follow-up with regard to the amount of medical treatment needed to control the intraocular pressure and to determine the usefulness in preventing further nerve damage. If ALT is equal to or better than medicine, efforts will be made to continue, and to possibly expand, the study for five more years to follow the status of the optic nerve in both groups of eyes. 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 to 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 medical) to control IOP will have subsequent topical medication(s) added in a stepwise fashion according to a protocol. The trial will involve a total of 6 Clinical Centers, a Data Coordinating Center, a Disc Stereophoto Reading Center, and a Visual Field Reading Center.