5-FLUOROURACIL AND GLAUCOMA FILTERING SURGERY

本研究是一项多中心临床试验，旨在确定 术后球结膜下注射5-氟尿嘧啶 （5-FU）增加滤过手术的成功率， 病人的身体状况不佳。 据估计，344 药物不受控制的青光眼患者，214例， 既往白内障摘除术和130例既往失败后 过滤手术，将需要满足统计 研究的要求。 为了得到这些病人， 估计共有415名患者（所有中心），258名患者在 既往白内障摘除术和157例既往失败后 过滤手术，必须进行筛选，并提供登记， 书房 小梁切除术后，患者将 随机接受标准手术治疗或 标准手术加预防性5-FU 5-FU组将 接受5 mg 5-FU结膜下注射，每日两次 术后第1-7天，术后每天一次 8-14. 所有的病人都将接受一个月，三个月， 术后6个月和1年。 用于随机化 和分析，患者将被分为四组： (1)年龄小于50岁的无晶状体眼;（2）50岁的无晶状体眼 年龄或更大;（3）有晶状体眼，一次滤过失败 （4）有晶状体眼，两次或两次以上滤过失败 程序. 成功率和失败率将根据 定义眼内压水平的基础。 眼内 将以标准化的方式进行压力测定 被戴着面具的人用戈德曼 眼压计、Digilab呼吸眼压计和Schiotz眼压计。 可能的5-FU相关眼毒性将通过以下方法进行研究 进行术前和术后全面的眼部检查 包括视觉灵敏度的标准化测量， 标准视野检查和内皮细胞计数 行政职责和数据分析将由 迈阿密大学统计协调中心。 所有数据将提供给安全性和数据监查 委员会将监测方案依从性， 治疗安全性和结果，如果有指征，终止 加入任何或所有阶层。

This study is a multicenter clinical trial to determine if postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients with poor prognoses. It is estimated that 344 patients with medically uncontrolled glaucoma, 214 after previous cataract extraction and 130 after previous failed filtering surgery, will be needed to satisfy the statistical demands of the study. In order to obtain these patients it is estimated that a total of 415 patients (all Centers), 258 after previous cataract extraction and 157 after previous failed filtering surgery, must be screened and offered enrollment in the study. Following trabeculectomy, patients will be randomized to either standard surgical treatment alone or standard surgery with adjunctive 5-FU. The 5-FU group will receive subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1-7 and once daily on postoperative days 8-14. All patients will be examined one month, three months, six months, and one year following surgery. For randomization and analysis, patients will be stratified into four groups: (1) aphakic younger than 50 years of age; (2) aphakic 50 years of age or older; (3) phakic with one unsuccessful filtering procedure; (4) phakic with two or more unsuccessful filtering procedures. Success and failure rates will be calculated on the basis of defined intraocular pressure levels. Intraocular pressure determinations will be made in a standardized fashion by masked individuals certified in the use of the Goldmann tonometer, Digilab pneumotonometer,and Schiotz tonometer. Possible 5-FU related ocular toxicity will be studied by performing pre- and post-operative complete ocular examinations including standardized measurements of visual acuity, standardized perimetry, and endothelial cell counts. Administrative duties and data analysis will be performed by a Statistical Coordinating Center at the University of Miami. All data will be made available to a Safety and Data Monitoring Committee, which will monitor protocol compliance, evaluate treatment safety and results, and, if indicated, terminate enrollment into any or all strata.