5-FLUOROURACIL AND GLAUCOMA FILTERING SURGERY

这项研究是一项随机多中心临床试验，以确定 术后5-氟尿嘧啶结膜下注射增加 预后不良患者行滤过手术的成功率。它 据估计，344名医学上无法控制的青光眼患者，214人 上一次白内障摘除后和130次上一次滤过失败后 为了满足这项研究的统计要求，需要进行手术。在……里面 为了获得这些患者，估计总共有415名患者 (所有中心)，258人接受白内障摘除手术，157人接受白内障摘除手术 必须对以前失败的滤过手术进行筛查并提供登记 在书房里。小梁切除术后的患者将被随机分为 要么只接受标准手术治疗，要么接受标准手术 辅助性5-FU。5-FU组将接受结膜下注射 5-氟尿嘧啶5 mg，术后第1天开始，连续2次 术后第1-7天每日1次，术后每天1次 8-14。所有患者将接受一个月、三个月和六个月的检查 手术后几个月和一年。为了进行随机化和分析， 患者将被分成四组：(1)50岁以下的无晶状体眼 年龄；(2)50岁或以上的无晶状体者；(3)有晶状体者。 不成功的过滤程序；(4)有两个或两个以上不成功的有晶状体障碍症 过滤程序。成功率和失败率将根据 定义的眼内压水平的基础。眼内压 决定将由戴面具的个人以标准化的方式进行 经过Goldmann压平眼压计和Digilab的使用认证 气压计。可能与5-FU有关的眼毒性将通过以下方法进行研究 进行手术前和手术后的全面眼科检查，包括 (标准化视力测量)标准化角膜曲率计， 标准化视野、裂隙灯摄影和内皮细胞 算了。行政职责和数据分析将由 统计安全和数据监测委员会，将监测 协议遵从性，评估治疗安全性和结果，如果 表明，终止任何或所有阶层的注册。

This study is a randomized 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 5mg of 5-FU starting on the first postoperative day and continuing twice daily on postoperative days 1-7, and once daily on postoperative days 8-14. All patients will be examined one month, three months, and 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 applanation tonometer and the Digilab pneumotonometer. Possible 5-FU related ocular toxicity will be studied by performing pre and post-operative complete ocular examinations including (standardized measurement of visual acuity) standardized keratometry, standardized perimetry, slit lamp photography, and endothelial cell counts. Administrative duties and data analysis will be performed by a Statistical 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.