5-FLUOROURACIL FILTERING SURGERY STUDY

本研究的目的是确定阿司匹林的安全性和有效性 结膜下注射5-氟尿嘧啶213例持续随访 参加氟尿嘧啶滤过手术临床试验(FFSS)的患者。 第一个五年资助期使招聘213人成为可能 属于无晶状体症高危类别的患者(包括 人工晶状体眼)，滤过手术失败。所有符合条件的患者都是 手术前和手术后的随机对照检查 标准化的观察者条件。视力、视野和 眼压测量以统一的方式在 所有七个中心：迈阿密大学、佛罗里达大学、大学 伊利诺伊州大学华盛顿大学洛雷恩社区医院 南加州大学和爱荷华大学。 具体目标是： 1.确保对所有213人进行完整、准确的五年随访 患者参加了FFSS，这是一项随机对照临床试验。至 评估术后结膜下切开术的长期风险和益处 注射5-FU。以确定是否存在非常显著的差异 5-FU组术后1年眼压控制维持不变 五年了。安全和数据监测委员会建议 对所有患者进行为期五年的随访，以确定是否长期有效 好处，以视觉稳定性衡量的视觉功能的保存 视野和视力的维持，5-FU组或 标准手术组。 2.确定长期眼压控制与眼压的因果关系 晚期青光眼患者视功能的保护 损坏。这将提供有关科学研究的重要信息 晚期青光眼患者降低眼压的价值 疾病。 3.与FFSS调查人员合作准备演示文稿和 出版并生成风险因素的分组分析。第一 描述短期疗效和不良事件的出版物将是 在对所有患者进行了跟踪治疗后，于1989年秋季出版 至少一年。未来的出版物将报告分组分析和 年龄、种族、眼部炎症性疾病、L和 既往眼科手术次数。

The goal of this study is to determine the safety and efficacy of subconjunctivally injected 5-FU through the continued follow-up of 213 patients in the Fluorouracil Filtering Surgery Study Clinical Trial (FFSS). The first five year funding period made possible the recruitment of 213 patients who fell in the high risk categories of aphakia, (including pseudophakia) and failed filtering surgery. All eligible patients were randomized and examined both pre-operatively and postoperatively under standardized observer conditions. Visual acuities, visual fields, and intraocular pressure measurements were performed in a uniform fashion at all seven centers: University of Miami, University of Florida, University of Illinois, Washington University, Lorain Community Hospital, University of Southern California, and University of Iowa. The specific aims are: 1. To assure the complete and accurate five year follow-up of all 213 patients enrolled in the FFSS, a randomized, controlled clinical trial. To assess long-term risks versus benefits of postoperative subconjunctival injections of 5-FU. To determine if the highly significant difference in IOP control after one year follow-up in the 5-FU group is maintained after five years. The Safety and Data Monitoring Committee has recommended following all patients for five years to determine if the long-term benefit, preservation of visual function as measured by stability of visual field and maintenance of visual acuity, is greater in the 5-FU group or in the standard surgery group. 2. To determine the causal relation of long-term IOP control to preservation of visual function in patients with advanced glaucomatous damage. This will provide important information regarding the scientific merit of IOP reduction in the subset of glaucoma patients with advanced disease. 3. To collaborate with FFSS investigators in preparing presentations and publications and to generate subgroup analysis of risk factors. The first publication describing short-term efficacy and adverse events will be published in the fall of 1989 after all patients have been followed for at least one year. Future publications will report subgroup analyses and the effect of risk factors such as age, race, ocular inflammatory disease,l and number of previous ocular operations.