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临床试验/IRCT2013040310241N1
IRCT2013040310241N1已完成未知

Efficacy of probing accompanied by mitomycin-c for treatment of complete, primery nasolacrimal duct obstruction in adults in Jahrom Mottahari hospital between 1386-88

Jahrom University of Medical Sciences0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
140

研究概览

简要总结

The current study aimed to determine the efficacy of probing with adjunctive mitomycin C (MMC) as a treatment for nasolacrimal duct obstruction (NLDO) in adults and to study the association of probing success with demographic and obstruction characteristics. This was a prospective, randomized, double-blind, placebo-controlled trial including 140 patients (each with a unilateral NLDO) scheduled for nasolacrimal probing who were randomly assigned to receive MMC (0.2 mg/ml, 70 patients; group A) or placebo (normal saline, 70 patients; group B). Irrigation was carried out with 0.5 cc of MMC (0.2 mg/mL) in the duct with a nasal pack for 10 minutes in group A. Patients' postprobing epiphora was evaluated at 2 weeks and 1, 3, 6, and 9 months postoperatively. Probing was judged to be a success if there was no or mild watering for at least 9 months after the procedure. There were no significant differences between the two study groups in demographic characteristics or duration of the operation (p=0.062). The overall success rate of probing with MMC was 47/70 (67.1%), which was significantly higher than the success rate of the procedure with placebo (p=0.0027). When the sex of the patients was controlled for by logistic regression, a significant association between the failure rate of probing and increasing age was found in cases and controls (p=0.004 vs. p=0.006, respectively). No significant side effects of probing with MMC were noted after 9 months of follow-up. Administering MMC in a dosage of 0.2 mg/mL during nasolacrimal probing significantly increased the success rate of probing. The failure rate of probing increased with age. A low dose of MMC is cheap, safe, and easily accessible; thus, it is recommended during nasolacrimal probing, especially in patients who refuse dacryocystorhinostomy surgery.
KEYWORDS:
Adult; Lacrimal duct obstruction; Mitomycin

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 100 years(—)
性别
All

入选标准

  • 1. Adults aged 18 or more.
  • 2. Both sexes of men and women.
  • 3. Patients with chief complaint of epiphora.
  • Exclusion criteria:
  • 1. Eye trauma.
  • 2. Nasal structure abnormalities.
  • 3. lacrimal system tumors.

排除标准

  • 未提供

研究者

发起方
Jahrom University of Medical Sciences

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