Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Munk's scale for epiphora grading
研究概览
简要总结
Primary acquired nasolacrimal duct obstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with primary acquired nasolacrimal duct obstruction (PANDO)
排除标准
- •Patients who are pregnant, with previous lacrimal procedure, upper lacrimal drainage obstruction, punctal stenosis, active dacryocystitis, dacryolithiasis, traumatic obstruction or lacrimal mass
研究组 & 干预措施
4-point group
Balloon dacryoplasty with LacriCATH® at 4 different points in the nasolacrimal duct
干预措施: 4 point balloon dacryoplasty with LacriCATH® (Device)
2-point group
Balloon dacryoplasty with LacriCATH® at 2 different points in the nasolacrimal duct
干预措施: 2 point balloon dacryoplasty with LacriCATH® (Device)
结局指标
主要结局
Munk's scale for epiphora grading
时间窗: From enrollment to 6 months after intervention
The frequency of epiphora will be evaluated at each follow-up visit using the Munk's scale, in which patients rate the frequency of tearing on a standardized 0-5 scale based on daily symptoms (as below). Grade 0: no epiphora Grade 1: epiphora requiring dabbing less than twice a day Grade 2: epiphora requiring dabbing 2-4 times a day Grade 3: epiphora requiring dabbing 5-10 times a day Grade 4: epiphora requiring dabbing more than 10 times a day Grade 5: constant epiphora The higher the grade, the worse the condition.
次要结局
- Tear meniscus height(For enrollment to 6 months after intervention)
- Patency of the nasolacrimal system assessed by probing and irrigation of the nasolacrimal duct(For enrollment to 6 months after intervention)