PURPOSE: To compare the intermediate-term efficacy of 5-fluorouracil (5-FU) and Mitomycin C (MMC) as adjunctive antimetabolites in neovascular glaucoma (NVG) filtration surgery.
METHODS: Forty consecutive eyes of 40 patients with NVG refractory to medical therapy were randomized to receive antimetabolite-augmented trabeculectomy. Eighteen eyes received postoperative 5-FU (5-FU group) and 22 eyes received intraoperative, low-dose (0.2 mg/ml) MMC for 2 mins (MMC group). The main outcome measure was intraocular pressure (IOP). Surgical success was defined as IOP < 21 mmHg with topical treatment (qualified success) or without topical treatment (complete success). Surgical failure was defined as IOP > or = 21 mmHg, despite postoperative topical treatment, and by postoperative blindness.
RESULTS: The mean follow-up period was 35.8 +/- 22.6 months in the 5-FU group and 18.6 +/- 17.2 months in the MMC group. This difference was not significant. Mean IOP decreased from 40.4 +/- 10.3 mmHg to 14.7 +/- 3.4 mmHg (p < 0.0001) in the 5-FU group and from 42 +/- 11.3 mmHg to 22.9 +/- 13.3 mmHg (p = 0.0006) in the MMC group; however, the difference between the 5-FU and MMC groups was not significant at any point. The success rate in the 5-FU group was 55.5% (44.4% complete, 11.1% qualified), compared with 54.5% (9.1% complete, 45.4% qualified) in the MMC group. This difference was not significant.
CONCLUSIONS: The percentage of patients who achieved postoperative IOP < 21 mmHg was similar in both groups, although a larger proportion of patients treated with MMC-augmented trabeculectomy required topical treatment in comparison with the 5-FU group.
PURPOSE: To compare the safety and efficacy of intraoperative 5-fluorouracil (5-FU) or Intraoperative mitomycin C (MMC) in eyes undergoing primary trabeculectomy.
DESIGN: Prospective double-masked randomized clinical trial.
METHODS: One hundred fifteen eyes of 103 patients with uncontrolled intraocular pressure (IOP) despite maximally tolerated medical therapy or laser were prospectively randomized in a double-masked fashion to one of two treatment groups in a single institution setting. Subject's eyes underwent primary trabeculectomy with either topical 5-FU (50 mg/ml for 5 minutes) or topical MMC (0.2 mg/ml for 2 minutes). Primary outcome measures included the number of eyes achieving target pressures of 21, 18, 15, and 12 mm Hg at 6 and 12 months postoperatively. Secondary outcome measures included IOP, best-corrected visual acuity, complications, and interventions.
RESULTS: Of the 115 eyes, 57 received 5-FU while 58 received MMC. A target IOP of 21 mm Hg at 6 months was achieved in 53 of 56 (95%) eyes in the 5-FU group and 54 of 57 (95%) eyes in the MMC group (P = 1.00). At 12 months, 45 of 48 (94%) eyes in the 5-FU group met a target IOP of 21 mm Hg while 48 of 54 (89%) eyes in the MMC group did (P =.49). The most common complications in each group were persistent choroidal effusions and bleb leak.
CONCLUSION: Our study suggests that intraoperative topical 5-FU is at least as effective as intraoperative topical MMC in reducing IOP of eyes undergoing primary trabeculectomy.
OBJECTIVE: To evaluate the relative efficacy and safety of 5-fluorouracil (5-FU) and mitomycin C (MMC) when used as adjuncts with primary trabeculectomy in eyes not at high risk for failure.
DESIGN: Prospective multicenter, randomized clinical trial.
PARTICIPANTS: One hundred thirteen patients with primary open-angle, pseudoexfoliative, pigmentary, or angle-closure glaucoma undergoing primary trabeculectomy were recruited.
METHODS: One eye of each patient was randomized to receive either 5-FU (50 mg/ml for 5 minutes) or MMC (0.4 mg/ml for 2 minutes).
MAIN OUTCOME MEASURES: Intraocular pressure (IOP), visual acuity, complications, and interventions were documented at fixed intervals after surgery. The study also examined progression of visual field loss, long-term complications, and bleb appearance 3 years after surgery.
RESULTS: Of the 108 patients with complete perioperative information, 54 eyes received 5-FU and 54 received MMC. The proportion of patients reaching different predefined target IOPs after surgery was slightly higher in the MMC group than in the 5-FU group. This difference was less than 25%, which would have been necessary to achieve statistical significance with a power of 0.8 and the sample size used. Likewise, there was no statistically significant difference between the groups with regard to mean preoperative IOP, complications, or interventions. Mean postoperative follow-up was 309 and 330 days in the 5-FU and MMC groups, respectively (P = 0.593).
CONCLUSIONS: 5-Fluorouracil and MMC were found to be equally safe and effective adjuncts to primary trabeculectomy in the short- and medium-term postoperative periods.
PURPOSE: To evaluate the risk of hypotony and hypotony maculopathy following trabeculectomy with 5-fluorouracil (5-FU) and mitomycin C (MMC) in a black West African population.
METHODS: One hundred and one eyes of black Ghanaian patients with advanced primary open-angle glaucoma received intraoperative antifibrotic therapy with trabeculectomy as part of two randomized clinical trials. Overall, 57 patients received 5-FU (50.0 mg/ml for 5 minutes) and 44 received MMC (0.5 mg/ml for 3.5 minutes). All cases were performed by one of five surgeons at a single outpatient surgery center.
RESULTS: Two of 101 eyes had a final intraocular pressure (IOP) of less than 5 mm Hg and were thus classified as having hypotony. No patient in either group was noted to develop hypotony-related maculopathy. Overall mean pre- and postoperative IOPs were 30.1 and 15.9 mm Hg, respectively. The patients receiving intraoperative MMC had a lower mean postoperative IOP (14.7 mm Hg) than those receiving 5-FU (first study, 17.1 mm Hg; second study, 16.7 mm Hg; p = 0.05). Mean overall follow-up was 17.7 months and did not differ significantly between the MMC and combined 5-FU groups.
CONCLUSION: Hypotony following trabeculectomy supplemented with antifibrotic agents is a rare complication in this population. No eyes in either clinical trial developed hypotony maculopathy, suggesting that the prevalence of this condition is substantially lower in black West Africans than in whites.
PURPOSE: To compare the effectiveness of intraoperative 5-fluorouracil (5-FU) and mitomycin C used adjunctively with trabeculectomy in a black West African population.
METHODS: Eighty-five consecutive eyes of 85 black patients undergoing primary trabeculectomy for open-angle glaucoma were prospectively randomly assigned to receive either 5-FU (50 mg/ml for 5 minutes) or mitomycin C (0.5 mg/ml for 3 1/2 minutes) intraoperatively by soaked sponge.
RESULTS: Of the 81 eyes with at least a 3-month postoperative follow-up, 41 of 44 (93.2%) in the mitomycin C group and 27 of 37 (73.0%) in the 5-FU group had a final intraocular pressure of less than 21 mm Hg (P = .01). Twenty-eight of 44 eyes (63.6%) in the mitomycin C group and 18 of 37 (51.4%) in the 5-FU group had a final intraocular pressure of less than 15 mm Hg (P = .26). Mean postoperative intraocular pressure was 13.7 mm Hg in the mitomycin C group and 16.3 mm Hg in the 5-FU group (P = .05). There were no differences between the two groups in mean age, preoperative intraocular pressure, postoperative visual acuity, and complications. Mean follow-up was 10.0 +/- 4.41 months (range, 4 to 19 months).
CONCLUSIONS: The adjunctive use of mitomycin C with trabeculectomy is equally safe and more efficacious compared to 5-FU in this West African population. Use of mitomycin C in this study was not associated with a statistically significantly greater proportion of patients achieving low intraocular pressure (less than 15 mm Hg) compared to 5-FU.
PURPOSE: Previous studies have shown that 5-fluorouracil (5-FU) and mitomycin C enhance the success rate of filtration surgery in aphakic eyes. However, eyes with posterior chamber implants have not been specifically studied. This study was performed to compare the safety and efficacy of 5-FU with that of mitomycin C in eyes that have posterior chamber implants and undergo filtration surgery for uncontrolled glaucoma.
METHODS: Eighty eyes of 74 patients who had previous cataract surgery with posterior chamber implants and who subsequently required trabeculectomy for uncontrolled open-angle glaucoma were randomized to receive either subconjunctival postoperative 5-FU or intraoperative mitomycin C.
RESULTS: Twelve months after surgery, intraocular pressures (IOPs) averaged 12.8 +/- 5.5 mmHg (mean +/- standard deviation) in the mitomycin C group and 14.8 +/- 3.8 mmHg in the 5-FU group (P = 0.001). Mitomycin C-treated eyes received an average of 0.6 medications for IOP control, and 5-FU-treated eyes received an average of 1.05 medications (P = 0.03). There was no significant difference in complications between the two groups.
CONCLUSION: Mitomycin C appears to be a viable alternative to 5-FU in patients with posterior chamber implants with uncontrolled glaucoma who require filtration surgery.
PURPOSE: To compare the outcome of filtering surgery in high-risk patients using intraoperative mitomycin C (MMC) versus postoperative 5-fluorouracil (5-FU).
METHODS: In a randomized clinical trial, the use of postoperative subconjunctival injections of 5-FU in 19 eyes of 19 patients was compared with a single intraoperative application of MMC in 20 eyes of 20 patients. All eyes were at high risk for failure of glaucoma filtering surgery.
RESULTS: Follow-up ranged from 26 to 38 months (mean, 32.0 months). Three eyes in the MMC-treated group and two eyes in the 5-FU-treated group required subsequent surgery to control the IOP. Excluding these patients, intraocular pressure (IOP) averaged 9.0 +/- 4.9 mmHg in the MMC-treated eyes versus 16.3 +/- 4.6 mmHg in the 5-FU-treated eyes at the patient's last visit (P = 0.0003). Of the MMC-treated eyes, 81.3% had IOPs less than or equal to 12 mmHg compared with 26.7% of eyes in the 5-FU group (P = 0.0023). In the MMC-treated group, the average number of medications for IOP control at last visit was 0.5 +/- 0.8 compared with 1.6 +/- 1.3 in the 5-FU-treated group (P = 0.01). Late postoperative complications (those occurring more than 3 months after surgery) were similar for the two groups, with the exception of formation of a Tenon cyst in three of the eyes treated with MMC compared with none of the 5-FU-treated eyes.
CONCLUSIONS: Eyes treated with MMC have lower IOP on fewer medications than eyes treated with 5-FU. Late postoperative complications are similar with the exception of an increased incidence of Tenon cyst formation in the MMC-treated eyes.
