Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: A prospective randomized clinical trial☆
Presented in part at: American Academy of Ophthalmology Annual Meeting, October 20–23, 2002; Orlando.
Received 10 June 2003; accepted 5 September 2003.
Abstract
Purpose
To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
Design
Randomized controlled clinical trial.
Participants
Sixty patients with refractory glaucoma.
Intervention
Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
Main outcome measures
Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan–Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
Results
After a mean follow-up of 12.3 months, Kaplan–Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan–Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (P = 0.75 and P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
Conclusion
Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation.
1Department of Ophthalmology, University of Campinas, Campinas, Brazil
2Department of Ophthalmology, University of São Paulo, São Paulo, Brazil
3Princess Alexandra Eye Pavilion, University of Edinburgh, Edinburgh, United Kingdom
4Department of Ophthalmology, University of Tennessee, Memphis, Tennessee, USA
5Department of Ophthalmology, University of Montreal, Montreal, Canada
6Department of Ophthalmology, University of Uberlandia, Uberlandia, Brazil
Correspondence to Vital P. Costa, MD, Rua Bauru, 40. São Paulo, SP 01248-010 Brazil.
ABSTRACT