Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
研究概览
简要总结
To compare the clinical effects of low temperature plasma ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheterization in the treatment of lacrimal duct obstruction
详细描述
Low-temperature plasma technology has developed rapidly in recent decades and is now widely used in ophthalmology, otolaryngology, orthopedics, urology and other fields .The low-temperature plasma surgery system relies on a 100kHz radio frequency electric field to excite normal saline (0.9% NaCl) to generate plasma energy, and relies on a 50-100 μm plasma layer generated at the front of the plasma knife to perform precise cutting, ablation and hemostaxy. But the application of this technique in the field of lacrimal duct still needs the accumulation of clinical experience.This study was aimed to compare the clinical effects of low temperature plasma ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheterization in the treatment of lacrimal 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① sign the informed consent for this study Voluntarily
- •≥18 years old and < 70 years old (3) Single lacrimal tract obstruction was included in the study
- •no purulent secretion of lacrimal passage
排除标准
- •Patients who meet any of the following criteria will not be eligible for inclusion in this study:
- •Have a history of lacrimal duct surgery, including lacrimal duct catheterization, laser lacrimal duct plasty, etc
- •Have a history of allergy to hormones and antibiotics
- •congenital lacrimal duct malformation
- •nasal trauma and deformation ⑤ Patients with severe abnormal liver and kidney function and cardiovascular and cerebrovascular diseases In addition to lacrimal duct obstruction, there are other ophthalmic diseases ⑦ Exclude diabetes
- •Exclusion of pregnancy, lactation women ⑨ Not willing to participate in research
结局指标
主要结局
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
时间窗: Postoperatively 1 week, 1, 2, 3 months, 6 months
The degree of watering was evaluated and classified according to the following clinical symptoms: 1 = no epiphora, 2 = minimal epiphora outdoors but only with wind or cold, 3 = troublesome epiphora outdoors but not indoors, 4 = epiphora indoors and outdoors
次要结局
- Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score(Postoperatively 1 week, 1, 2, 3 months, 6 months)
- Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications(Postoperatively 1 week, 1, 2, 3 months, 6 months)