This study is a multicenter randomized clinical trial to determine if postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in glaucoma patients with poor prognoses. Patients with medically uncontrolled glaucoma who have had cataract surgery, unsuccessful filtering surgery, or both will be eligible. It is estimated that 405 patients, 252 patients with previous cataract surgery and 153 patients with previous filtering surgery, will be needed. Patients will be randomized to receive either standard surgery or standard surgery with adjunctive 5-FU injections. For randomization, patients who have had previous cataract surgery (with or without previous filtering surgery) will be stratified into two prognostic groups: 1) aphakic patients younger than 50 years of age; 2) aphakic patients 50 years of age or older. Patients who have had failed filtering surgery will also be stratified into two groups: 1) phakic patients who have had one unsuccessful filtering procedure; 2) phakic patients who have had two or more unsuccessful filtering procedures. The 5-FU treated patients will receive subconjunctival injections of 5mg of 5-FU immediately after surgery, twice daily on postoperative days 1-7, and once daily on postoperative days 8-14. The standard surgical patients will receive no injections and will be examined daily on postoperative days 1-14. All patients will be examined one month, six months and one year after surgery. Success and failure rates will be calculated on the basis of defined intraocular pressure levels. Postoperative intraocular pressure determinations will be made in a standardized fashion by individuals masked to the patient's treatment group. Possible concomitant risks of 5-FU treatment, such as toxic effects on the cornea, lens, or retina, will be monitored. The Statistical Coordinating Center will assist in the design of the clinical trial and will be responsible for data collection, management, and analysis. In addition, the Coordinating Center will perform the administrative duties of the Study, and will organize and document meetings of the Executive, Steering, and Safety and Data Monitoring Committees.
