Don Liu1, Thomas M Bosley. 1. Department of Ophthalmology, University of Missouri, 1 Hospital Drive, Room EC 139, Columbia, MO 65212, USA. LiuD@health.missouri.edu
Abstract
OBJECTIVE: To determine if mitomycin-C (MMC) application during silicone intubation (SI) can effectively substitute for dacryocystorhinostomy (DCR) or Jones tube insertion. DESIGN: A prospective, randomized, double-masked study. PARTICIPANTS: Twenty-four patients (7 males, 17 females; aged 2-69 years) with 27 eyes (three bilateral cases) with an obstructed lacrimal system who were candidates for DCR or Jones tube. METHODS: All study patients underwent SI with application in a randomized, double-masked fashion of MMC or placebo, with the former receiving 0.2 mg/ml MMC for 2 minutes before SI. MAIN OUTCOME MEASURES: Clinical assessment of tearing and discharge; Schirmer I and II tests at 1, 3, 6, and 12 months; and the need for eventual DCR or Jones tube insertion. RESULTS: Follow-up ranged from 13 to 23 months (mean, 18 months; median, 17 months). Seven of the 12 eyes in the MMC group and 8 of the 15 eyes in the placebo group had a successful outcome and remained symptom free. The difference was not statistically significant (P = 0.79). Dacryocystorhinostomy or Jones tube was performed in five eyes in the MMC group and in seven eyes in the placebo group 3 to 18 months later; all had successful outcome and no complications. Untoward effects of MMC application included a slit canaliculus and a transient conjunctival injection. A successful outcome using this combined technique does not appear to correlate with age, gender, laterality, and intraoperative bleeding observed at the punctum or for the duration of symptoms. CONCLUSIONS:Mitomycin-C application during SI did not benefit outcome. Complications from such application were mild and infrequent.
RCT Entities:
OBJECTIVE: To determine if mitomycin-C (MMC) application during silicone intubation (SI) can effectively substitute for dacryocystorhinostomy (DCR) or Jones tube insertion. DESIGN: A prospective, randomized, double-masked study. PARTICIPANTS: Twenty-four patients (7 males, 17 females; aged 2-69 years) with 27 eyes (three bilateral cases) with an obstructed lacrimal system who were candidates for DCR or Jones tube. METHODS: All study patients underwent SI with application in a randomized, double-masked fashion of MMC or placebo, with the former receiving 0.2 mg/ml MMC for 2 minutes before SI. MAIN OUTCOME MEASURES: Clinical assessment of tearing and discharge; Schirmer I and II tests at 1, 3, 6, and 12 months; and the need for eventual DCR or Jones tube insertion. RESULTS: Follow-up ranged from 13 to 23 months (mean, 18 months; median, 17 months). Seven of the 12 eyes in the MMC group and 8 of the 15 eyes in the placebo group had a successful outcome and remained symptom free. The difference was not statistically significant (P = 0.79). Dacryocystorhinostomy or Jones tube was performed in five eyes in the MMC group and in seven eyes in the placebo group 3 to 18 months later; all had successful outcome and no complications. Untoward effects of MMC application included a slit canaliculus and a transient conjunctival injection. A successful outcome using this combined technique does not appear to correlate with age, gender, laterality, and intraoperative bleeding observed at the punctum or for the duration of symptoms. CONCLUSIONS:Mitomycin-C application during SI did not benefit outcome. Complications from such application were mild and infrequent.