Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- recanalization of nasolacrimal duct
研究概览
简要总结
The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies
详细描述
The study will be conducted on children above 2 year and will be divided randomly into two groups:
Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
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)
盲法说明
all will be know the surgical procedure but participant will know only that he will be treated but cant understand type of procedure done
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in the age group above 2 years old
- •No history of previous probing.
- •No history of previous intubation.
- •Children with no any other association or congenital anomalies cause watery eye.
- •children suffer from congenital nasolacrimal duct obstruction.
排除标准
- •children less than 2 years old.
- •previous probing.
- •previous intubation.
- •children with any other congenital anomalies as congenital ectropion , congenital entropion
- •children suffer from any upper lacrimal anomalies as obstruction or stenosis.
结局指标
主要结局
recanalization of nasolacrimal duct
时间窗: 6 months
compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by 1. epiphora (overflow of tears onto the face) 2. increase tear film meniscus ( more than 1mm in height) 3. mucous discharge 4. Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)
次要结局
- complication(6 months)
研究者
Sameh Hassan Abdelbaky
Assistant Professor of Ophthalmology.
Cairo University