THE EFFECT OF MITOMYCIN-C ON MOLTENO IMPLANT-SURGERY - A 1-YEAR RANDOMIZED, MASKED, PROSPECTIVE-STUDY

Purpose: The authors assess whether adjunctive mitomycin C improves Mo lteno tube shunt surgery in terms of intraocular pressure (IOP), visua l acuity, and complication rates. Patients and Methods: Twenty-five ey es of twenty-five consecutive patients undergoing double-plate Molteno implant surgery were randomized to receive either mitomycin C (MMC) 0 .4, mg/mL for 2 minutes or a control balanced salt solution in a maske d, prospective study. Intraocular pressure, visual acuity, and complic ations were recorded 1 week and 1, 3, 6, and 12 months after surgery. A repeated measures analysis of variance (ANOVA) model was used to tes t the overall effect of the drug on IOP and percent change from preope rative IOP. Results: Thirteen eyes received balanced salt solution and 12 eyes received MMC. There was no difference between the groups with respect to age, preoperative IOP, log mean angle of resolution (LogMa r) visual acuity, or number of preoperative medications. Except for we ek 1, there were no differences between the groups at any of the clini c visits with respect to IOP and percent change from baseline IOP. Ana lysis of the visual acuity (LogMar) showed reduction in vision for bot h groups. Complications were similar in each group, as were number of postoperative hypotensive agents required. Conclusions: Adjunct MMC do es not demonstrate a significant difference in outcomes compared with placebo in pressure-ridged Molteno implant surgery. Results of this st udy are limited by a small number of patients in each group and a fixe d dose of MMC.