Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Epiphora
研究概览
简要总结
In Mexico, upper lacrimal duct obstruction (ULDO) is a common pathology, and the standard surgical treatment is closed dracryointubation. Based on statistics from our headquarters, in 30% of cases there is a failure of the technique and recurrence of symptoms due to associated complications. Because of this, the application of a self-stable bicananlicular intubation set is proposed. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (FCI) and closed dacryointubation in patients with ULDO .
详细描述
Upper lacrimal duct obstruction (ULDO) or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point, in superior and inferior canaliculi, or in the common canaliculus. When the ULDO is at the level of the canaliculi (superior, inferior or common), the alternatives available for its management are closed dacryointubation with Crowford catheter, conjunctivadacryocystorhinostomy, and bicanalicular intubation.
Closed dacryointubation with Crowford tube is a technique effective in approximately 90% of children diagnosed with congenital occlusion of the lacrimal duct, however, in adults the reported surgical success rate is lower, approximately 70% according to different authors.
The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction.
The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set (FCI R), an FDA-approved silicone bicanalicular retention device, is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction.
The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (ICF) and closed dacryointubation in patients with ULDO
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients with stenosis and incomplete obstruction of the upper lacrimal duct with epiphora > 2 on the Munk scale who have not previously undergone surgery on the affected tear duct
- •Patients who may undergo general anesthesia and sedation
- •Patients who are able to present and continue follow-up for the duration of the study
- •Acceptance to participate in the study by signing an informed consent
排除标准
- •Patients with ocular surface involvement affecting the upper lacrimal duct, such as blepharitis with tear point epithelialization
- •Patients with lacrimal point malposition and/or eyelid malposition due to entropion or ectropion
- •Patients with congenital or acquired obstruction of the lower lacrimal duct
- •Patients with a history of facial paralysis
- •Patients with systemic inflammatory disease such as scarring pemphigoid or Steven Johnson
- •Patients in whom tumour involvement of the lacrimal duct is suspected
- •Patients with reflex tear hypersecretion due to ocular surface involvement or other causes.
- •Pregnancy and breastfeeding
- •Active infection, eye trauma, history of facial trauma with broken bones of the nose, or history of sinus surgery.
结局指标
主要结局
Epiphora
时间窗: one, three and four months after surgery
evidence of epiphora as told by the subject
Irrigation of tha lacrimal duct
时间窗: three and four months after the procedure
Irrigation of the lacrimal duct with saline solution to seek for permeability
次要结局
- Occurrence of epistaxis(one, three and four months after surgery)
- Presence of extrusion of bicanalicular intubation tubes(one, three and four months after surgery)
- How well is the positioning of the silicone tubes(one, three and four months after surgery)