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.
