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临床试验/NCT03242681
NCT03242681Unknown不适用

Endoscopy Assisted Probing Versus Simple Probing in Patients With Primary Congenital Nasolacrimal Duct Obstruction: A Randomized Clinical Trial

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2017年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
320
试验地点
1
主要终点
success rate

研究概览

简要总结

The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with the standard simple probing in cases with congenital nasolacrimal duct obstruction . Furthermore, investigators will identify associated anatomical anomalies. Investigators believe results of this study can be valuable in better understanding of this disease and provide a high evidence level necessary to propose a classification and management algorithm.

Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction, no past surgical management, with one or more of the below criteria will be included:

  1. Non-resolving symptoms of epiphora and/or discharge.
  2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics.
  3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and patients will undergo lacrimal tests before and after operation in one week, one month and 3months based on a special record form. Patients will be randomly assigned to "simple probing" group or "endoscopy assisted probing" group.

All operations will be performed in operative theater and under general anesthesia. Pre- and post-operative examinations will be performed in plastic clinic in Farabi hospital.

详细描述

Congenital nasolacrimal duct obstruction is the most common cause of epiphora in infancy that can occur in 5% of newborn infants. It may resolve spontaneously in 95% of patients during the first year of life.(1) After that time surgical intervention is justified. Epiphora after birth is most commonly secondary to a developmental anomaly of imperforated membrane (Hasner valve) in distal part of nasolacrimal duct. Patients with congenital nasolacrimal duct obstruction (CNLDO) may show epiphora, eye discharge, acute dacryocystitis and cellulitis and dacryocele. Currently the management of primary CNLDO includes conservative treatment including lacrimal sac massage and topical antibiotics until 12 months of age.

The standard intervention for non-complicated, unresolved cases is simple blind probing of nasolacrimal duct. The overall success rate of one time simple probing is 75%-95 %. Simple probing is performed through a blind passage of a malleable metallic probe through punctum to nasolacrimal duct and inferior meatal space in nasal cavity.Although effective, probing may be associated with traumatic nasal bleeding, nasal mucosal damage,punctal and canalicular injury and false passage. The trauma is further concerned during stent insertion.In the past decade improvement in endoscopic instruments and techniques enabled us to visualize and smoothly manipulate anomalies in the nasal cavity and especially in the inferior meatus. Endoscopic assisted probing has been proposed as a measure to increase accuracy, efficacy and safety of nasolacrimal probing. Furthermore, by this method intranasal pathologies associated with failure of probing could be accurately diagnosed and specifically treated. To the best of our knowledge literature addressing this issue is limited to few limited case series.

The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with the standard simple probing in cases with congenital nasolacrimal duct obstruction . Furthermore, investigators will identify associated anatomical anomalies. Investigators believe results of this study can be valuable in better understanding of this disease and provide a high evidence level necessary to propose a classification and management algorithm.

Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction, no past surgical management, with one or more of the below criteria will be included:

  1. Non-resolving symptoms of epiphora and/or discharge.
  2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics.
  3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and patients will undergo lacrimal tests before and after operation in one week, one month and 3months based on a special record form. Patients will be randomly assigned to "simple probing" group or "endoscopy assisted probing" group.

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 (Outcomes Assessor)

入排标准

年龄范围
3 Weeks 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age: 3 weeks<Age<6 years
  • epiphora or discharge since birth or within 8 weeks after birth

排除标准

  • Follow up less than 3 months
  • Epiphora secondary to etiologies than congenital naso-lacrimal duct obstruction such as puncta/canalicular aplasia/dysgenesis;midfacial anomalies; congenital eyelid malposition;epiblepharon; trichiasis; congenital glaucoma, tumors; blepharitis; trauma Treatment success: defined success absence of epiphora/lacrimation and discharge 6 months after intervention.

研究组 & 干预措施

Endoscopy Assisted Probing

Experimental

Endoscopy Assisted Probing

干预措施: Endoscopy Assisted Probing procedure (Procedure)

Simple Probing

Active Comparator

Simple Probing

干预措施: Endoscopy Assisted Probing procedure (Procedure)

结局指标

主要结局

success rate

时间窗: 6 months

absence of epiphora and discharge and negative dye disappearance test

次要结局

  • Incidence of Treatment-Emergent Adverse Events(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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