American journal of ophthalmology · 2025
Mitomycin C in Non-endoscopic Endonasal Dacryocystorhinostomy: A Randomized Clinical Trial Involving 442 Cases.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Mohapatra Samir, Rath Suryasnata, Kapoor Anasua G, Mohapatra Archisman, Ali Mohd Hasnat, Behera Minati, Jayakrishnan Ganeshkumar
Аннотация
PURPOSE: To evaluate whether 0.04% mitomycin C (MMC) application at the ostium enhances the outcome of non-endoscopic endonasal dacryocystorhinostomy (NEED) in individuals with primary acquired nasolacrimal duct obstruction (PANDO).
DESIGN: Prospective double-blind randomized clinical trial.
METHODS: Consenting adults with PANDO were recruited for this multicenter, double-blind, randomized clinical trial for superiority at 2 tertiary level eye care centers. Eligible participants scheduled to undergo NEED with intubation were randomized into the study (0.04% MMC application for 3 minutes) and control (no MMC) arms, and were followed up for 1 year. The primary outcome was structural patency by lacrimal irrigation at 6 months. Secondary outcome measures included sustained patency and complete relief from epiphora after NEED at 1 and 5 years.
RESULTS: A total of 442 patients met the study criteria and were recruited. A large majority were female (314; 71%). Study and control arms were comparable in age (44.0 ± 13.4 vs 43.4 ± 13.6 years; P = .64), sex, socioeconomic status, and side of surgery. The mean follow-up time for the MMC and control groups was 35.7 ± 26.8 vs 36.5 ± 28.0 months (median, 33 vs 35 months), respectively. Kaplan-Meier survival estimates for structural patency at 6 months was comparable between the MMC and control groups, with no statistically significant difference (log rank test, P = .74). Complete success in the MMC and control groups was 94.6% vs 95% at 1 year and 93% vs 94% at 5 years, respectively, showing excellent and comparable long-term outcomes. Granuloma at the ostium (4.5%) and prolapse of the tube (4.0%) were the most common complications and were comparable in both groups.
CONCLUSIONS: This large double-blind, randomized clinical trial showed that MMC (0.04% for 3 minutes) application at the ostium did not enhance the outcome in NEED for adults with PANDO, and its routine use should be reconsidered in this setting.
DESIGN: Prospective double-blind randomized clinical trial.
METHODS: Consenting adults with PANDO were recruited for this multicenter, double-blind, randomized clinical trial for superiority at 2 tertiary level eye care centers. Eligible participants scheduled to undergo NEED with intubation were randomized into the study (0.04% MMC application for 3 minutes) and control (no MMC) arms, and were followed up for 1 year. The primary outcome was structural patency by lacrimal irrigation at 6 months. Secondary outcome measures included sustained patency and complete relief from epiphora after NEED at 1 and 5 years.
RESULTS: A total of 442 patients met the study criteria and were recruited. A large majority were female (314; 71%). Study and control arms were comparable in age (44.0 ± 13.4 vs 43.4 ± 13.6 years; P = .64), sex, socioeconomic status, and side of surgery. The mean follow-up time for the MMC and control groups was 35.7 ± 26.8 vs 36.5 ± 28.0 months (median, 33 vs 35 months), respectively. Kaplan-Meier survival estimates for structural patency at 6 months was comparable between the MMC and control groups, with no statistically significant difference (log rank test, P = .74). Complete success in the MMC and control groups was 94.6% vs 95% at 1 year and 93% vs 94% at 5 years, respectively, showing excellent and comparable long-term outcomes. Granuloma at the ostium (4.5%) and prolapse of the tube (4.0%) were the most common complications and were comparable in both groups.
CONCLUSIONS: This large double-blind, randomized clinical trial showed that MMC (0.04% for 3 minutes) application at the ostium did not enhance the outcome in NEED for adults with PANDO, and its routine use should be reconsidered in this setting.