PURPOSE: The purpose of the study is to assess the effect of adjunctive intraoperative mitomycin C (MMC) in Molteno drainage device implantation for patients with recalcitrant glaucomas. METHOD: Forty-nine eyes of 49 patients who underwent one-stage, single-plate Molteno device implantation with adjunctive intraoperative MMC (0.5 mg/ml) for 3 to 5 minutes (MMC group) were compared to a historic control group of 51 eyes of 51 patients (control group) who received one-stage, single-plate Molteno device implantation without MMC. Success (survival) was defined as an intraocular pressure (IOP) between 6 and 21 mmHg, inclusive, with (qualified success) or without (complete success) glaucoma medications and with no additional glaucoma surgery, phthisis, implant removal, or loss of light perception. RESULTS: Preoperative conditions were similar between the two groups. There was no significant difference in surgical survival rate between the two groups (P = 0.13, log-rank test). There also were no significant differences in the postoperative IOP levels and numbers of antiglaucoma medications between the two groups at all times (P > 0.05). Visual acuity was improved or remained within one line of preoperative visual acuity in 76.1% of the MMC group and 78.7% of the control group at 1 year after surgery (P = 0.76, chi-square test). Complications and reoperation for complications were similar in both groups (P > 0.05, chi-square test) except for the incidence of early postoperative hypotony and the total number of eyes with complications not requiring reoperation, which were more common in the MMC group (P = 0.027, 0.005, respectively, chi-square test). The most common complications included hypotony with or without a flat anterior chamber or choroidal detachment, followed by hyphema and tube plugging. CONCLUSION:Molteno device implantation with adjunctive intraoperative MMC in patients with complicated glaucoma may not offer a better chance of surgical success compared with Molteno implantation without MMC.
RCT Entities:
PURPOSE: The purpose of the study is to assess the effect of adjunctive intraoperative mitomycin C (MMC) in Molteno drainage device implantation for patients with recalcitrant glaucomas. METHOD: Forty-nine eyes of 49patients who underwent one-stage, single-plate Molteno device implantation with adjunctive intraoperative MMC (0.5 mg/ml) for 3 to 5 minutes (MMC group) were compared to a historic control group of 51 eyes of 51 patients (control group) who received one-stage, single-plate Molteno device implantation without MMC. Success (survival) was defined as an intraocular pressure (IOP) between 6 and 21 mmHg, inclusive, with (qualified success) or without (complete success) glaucoma medications and with no additional glaucoma surgery, phthisis, implant removal, or loss of light perception. RESULTS: Preoperative conditions were similar between the two groups. There was no significant difference in surgical survival rate between the two groups (P = 0.13, log-rank test). There also were no significant differences in the postoperative IOP levels and numbers of antiglaucoma medications between the two groups at all times (P > 0.05). Visual acuity was improved or remained within one line of preoperative visual acuity in 76.1% of the MMC group and 78.7% of the control group at 1 year after surgery (P = 0.76, chi-square test). Complications and reoperation for complications were similar in both groups (P > 0.05, chi-square test) except for the incidence of early postoperative hypotony and the total number of eyes with complications not requiring reoperation, which were more common in the MMC group (P = 0.027, 0.005, respectively, chi-square test). The most common complications included hypotony with or without a flat anterior chamber or choroidal detachment, followed by hyphema and tube plugging. CONCLUSION: Molteno device implantation with adjunctive intraoperative MMC in patients with complicated glaucoma may not offer a better chance of surgical success compared with Molteno implantation without MMC.