Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
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
- 否
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
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)
