PURPOSE: To assess the efficacy of intraoperative mitomycin C (MMC) during silicone intubation (SI) as a substitute for dacryocystorhinostomy (DCR) in nasolacrimal duct obstruction (NLDO). METHODS: In this prospective, double-masked study, 88 patients with complete NLD obstruction who were candidates for DCR were randomized in 2 groups. All study patients underwent SI with application of MMC or placebo in a randomized, double-masked fashion, with the former receiving 0.2 mg/mL for 2 minutes before SI. RESULTS: After a mean follow-up interval of 8 months, 25 of the 43 eyes in the MMC group and 21 of the 44 eyes in the placebo group had a successful outcome and were free of tearing and discharge. No significant difference was noted between the 2 groups (p = 0.331). In patients with simple epiphora and less than 6 months of duration, SI alone was effective in 83% of patients; however, in the same group, MMC application during SI did not show beneficial effect over SI alone. But in patients with simple epiphora of 6-months duration or longer, the application of MMC during SI resulted in better efficacy compared with SI alone. The success rates in the patients that had chronic dacryocystitis was lower (23%) compared with patients that had only epiphora (63.7%). CONCLUSIONS:SI alone could effectively substitute for a more extensive procedure such as DCR in patients with simple epiphora, particularly those with newly developed symptoms. In cases with longer duration of symptoms of epiphora, application of MMC would increase the success rate significantly.
RCT Entities:
PURPOSE: To assess the efficacy of intraoperative mitomycin C (MMC) during silicone intubation (SI) as a substitute for dacryocystorhinostomy (DCR) in nasolacrimal duct obstruction (NLDO). METHODS: In this prospective, double-masked study, 88 patients with complete NLD obstruction who were candidates for DCR were randomized in 2 groups. All study patients underwent SI with application of MMC or placebo in a randomized, double-masked fashion, with the former receiving 0.2 mg/mL for 2 minutes before SI. RESULTS: After a mean follow-up interval of 8 months, 25 of the 43 eyes in the MMC group and 21 of the 44 eyes in the placebo group had a successful outcome and were free of tearing and discharge. No significant difference was noted between the 2 groups (p = 0.331). In patients with simple epiphora and less than 6 months of duration, SI alone was effective in 83% of patients; however, in the same group, MMC application during SI did not show beneficial effect over SI alone. But in patients with simple epiphora of 6-months duration or longer, the application of MMC during SI resulted in better efficacy compared with SI alone. The success rates in the patients that had chronic dacryocystitis was lower (23%) compared with patients that had only epiphora (63.7%). CONCLUSIONS:SI alone could effectively substitute for a more extensive procedure such as DCR in patients with simple epiphora, particularly those with newly developed symptoms. In cases with longer duration of symptoms of epiphora, application of MMC would increase the success rate significantly.