5-FLUOROURACIL AND GLAUCOMA FILTERING SURGERY

本研究是一项随机多中心临床试验，旨在确定 术后结膜下注射5-氟尿嘧啶（5-FU）增加 对视力较差的患者行滤过手术的成功率。 它 据估计，344例药物不受控制的青光眼患者，214 既往白内障摘除术后和既往滤过失败后130例 需要手术来满足研究的统计学要求。 在 为了获得这些患者，估计总共有415名患者 (all中心），258例既往白内障摘除术后和157例 必须筛选既往失败的滤过手术并提供入组 在书房里。 小梁切除术后，患者将随机分配至 单独的标准手术治疗或标准手术， 抗肿瘤5-FU。 5-FU组将接受结膜下注射 5 mg 5-FU，从术后第一天开始，持续两次 术后第1-7天每天一次，术后每天一次 8-14. 所有的病人都将接受一个月、三个月和六个月的检查 术后1个月和1年。 对于随机化和分析， 将患者分为四组：（1）年龄小于50岁的无晶状体眼 岁;（2）50岁或以上的无晶状体;（3）有晶状体眼， 滤过手术不成功;（4）有晶状体眼，两次或两次以上不成功 过滤程序。 成功率和失败率将根据 根据定义的眼内压水平。 眼压 将由戴口罩的人以标准化的方式做出决定 在Goldmann压平眼压计和Digilab的使用中获得认证 呼吸压力计 可能的5-FU相关眼毒性将通过以下方法进行研究 进行术前和术后完整的眼部检查，包括 （标准化测量视力）标准化角膜曲率计， 标准视野检查、裂隙灯摄影和内皮细胞 道理 行政职责和数据分析将由 统计安全和数据监查委员会将监查 方案依从性，评价治疗安全性和结果，如果 如有指示，则终止入组任何或所有分层。

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.