: A comparative study of efficacy of 0.02 percent MITOMYCIN-C VS 0.04 percent MITOMYCIN-C in probing in adults with primary acquired nasolacrimal duct obstruction : A prospective randomized interventional study .
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Improvement of subjective symptoms such as watering of eye.
研究概览
简要总结
This is a prospective randomized interventional study to compare the efficacy of 0.02% mitomycin c with 0.04% mitomycin c in adults with primary acquired nasolacrimal duct obstruction .
The current treatment modality of dacryocystorhinostomy to bypass the obstructed nasolacrimal duct has excellent outcomes . However , probing of nasolacrimal duct with mitomycin c offers an easy, effective and safe substitute to patients who are poor surgical candidates , elderly patients , patients who do not wish to undergo surgery , for buying time for surgery .
Goal is to find which concentration of mitomycin c offers more effective improvement in patients symptoms with less to no side effects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing for followup .
- •Patients with proven diagnosis of primary acquired nasolacrimal duct obstruction .
排除标准
- •Patients with acute dacrocystitis , associated with external fistula ,canalicular obstruction , lid malposition ,punctum agenesis, patients using drugs which causes punctal stenosis, ocular surface disorders, past history of trauma/probing/surgery.
结局指标
主要结局
Improvement of subjective symptoms such as watering of eye.
时间窗: Patients are followed up at 1 week , 4 weeks , 3 months , 6 months . At each followup , patients are questioned about subjective improvement in symptoms . Patency of nasolacrimal duct is confirmed by syringing .
次要结局
- N/A(N/A)
研究者
Dr Vanam Srinidhi
ESIC MEDICAL COLLEGE AND HOSPITAL