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临床试验/NCT00706251
NCT00706251已完成不适用

Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Patient being completely free of tearing.

研究概览

简要总结

For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard treatment, with a success rate of 80-90% according to literature. Another available treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.

In our study, we would like to find the efficacy of nasolacrimal duct intubation, which was performed in our medical center on a few hundred patients with mild epiphora.

Study hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is close in it's efficacy to the Dacryocystorhinostomy procedure.

详细描述

Under normal conditions, the amount of tears excreted from lacrimal glands to the eye is equal to the amount drained through the tear duct. Epiphora in adults usually involves a blockage of the lacrimal sac or the nasolacrimal duct. Epiphora causes tearing in patients, which can be treated sympthomatically in a conservative way (antibiotic treatment, probing of the tear duct, pressure irrigation of the tear duct) or therapeutic in an invasive way. The invasive treatment includes one of the following:

  1. Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear drainage.
  2. Nasolacrimal intubation - inserting a silicone tube through the tear duct. The tube is usually removed after 3-6 months.

Currently, there are only a few reports regarding the efficacy of nasolacrimal intubation, all with a small number of research subjects. Also, these reports have stratified the patients according to the location of the tear duct blockage, and didn't take into account the severity of the blockage (ie the severity of symptoms) prior to performing the intubation.

In our research, we would like to find the efficacy of nasolacrimal intubation which was performed in our medical center on a few hundred patients with mild epiphora, and to compare in with the efficacy of the Dacryocystorhinostomy - which is 80-90% according to literature.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of mild epiphora.
  • Underwent nasolacrimal intubation during 01/2000 - 12/2007.

排除标准

  • Purulent excretions from nasolacrimal duct on day of admission or intubation.
  • Nasolacrimal intubation in the past.
  • Dacryocystorhinostomy in the past.

结局指标

主要结局

Patient being completely free of tearing.

时间窗: 1 year.

次要结局

  • Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.(1 year)

研究者

申办方类型
Other

研究点 (1)

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