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临床试验/NCT01010659
NCT01010659已完成4 期

Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

Aurolab2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
Aurolab
入组人数
30
试验地点
2
主要终点
Resolution of epiphora

研究概览

简要总结

The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

详细描述

Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.

30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.

Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects having epiphora
  • Canalicular blockade ascertained with probing
  • Chronic dacryocystitis

排除标准

  • Absent puncta
  • Acute on chronic dacryocystitis
  • Noticeable lid laxity
  • Previous lacrimal surgery
  • Patients younger than 15 years
  • Suspicion of malignancy
  • Post traumatic lids
  • Bony deformity

研究组 & 干预措施

Lacrimal Tube

Experimental

Dacryocystorhinostomy with silicone lacrimal intubation

干预措施: Lacrimal Tube (Device)

结局指标

主要结局

Resolution of epiphora

时间窗: 15th Day, 1st Month, 6th Month and 12th month

次要结局

  • Post operative complications(15th Day, 1st Month, 6th Month and 12th Month)

研究者

发起方
Aurolab
申办方类型
Other

研究点 (2)

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