ARGON LASER TRABECULOPLASTY CLINICAL TRIAL

本方案是开展多中心随机临床试验的方案。 评估Ar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方案。这个 试验将涉及招募240名新诊断为 对称性开角型青光眼。仅限年龄在30岁或以上的患者 性别)，眼压为27毫米汞或更高，并有证据表明 两只眼睛的视神经损伤将有资格参加。这个 每个患者将接受至少两年的跟踪调查，以便 收集试验过程中压力水平的信息，并 提供视野损失率和增高率的对比数据 视神经拔火罐。治疗组将在实验结束时进行比较 关于医疗量的两年后续行动 需要控制眼压并确定其有效性 以防止进一步的神经损伤。如果ALT等于或大于 医学，将努力继续，并可能扩大， 再研究五年，以跟踪两者的视神经状况 一群群的眼睛。将随机选择要进行激光治疗的眼睛。Alt 将由96个烧伤部位组成，烧伤部位位于 小梁网，避开后部或葡萄膜网。烧伤的人 将以适当的强度输送，以使 在气泡形成的临界点(700到1200 mW之间)的网络 每个病变)。被指派接受药物治疗的同僚眼睛将被安置在 单一的局部用药。需要额外治疗的眼睛 初始治疗(即激光小梁成形术或单次局部治疗) 医疗)控制眼压将增加后续局部用药(S) 按照协议循序渐进的方式。这场审判将涉及 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.