Endoscopy Assisted Probing Versus Simple Probing in Primary Congenital Nasolacrimal Duct Obstruction

NCT03242681 | Unknown

• 1 other identifier: IR.TUMS.VCR.REC.1395.1200
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Non-resolving symptoms of epiphora and/or discharge.
2. 2.Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics.
3. 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.

Conditions

Congenital Nasolacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

• success rate

  absence of epiphora and discharge and negative dye disappearance test

  6 months

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  6 month

Study Arms (2)

Endoscopy Assisted Probing

EXPERIMENTAL

Endoscopy Assisted Probing

Procedure: Endoscopy Assisted Probing procedure

Simple Probing

ACTIVE COMPARATOR

Simple Probing

Procedure: Endoscopy Assisted Probing procedure

Interventions

Endoscopy Assisted Probing procedure PROCEDURE

The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system

Endoscopy Assisted Probing; Simple Probing

Eligibility Criteria

• Age: 3 Weeks - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Farzad Pakdel

Tehran, Iran

Location

Study Officials

• Farzad Pakdel, M.D.

  Farabi Hospital, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2017
• First Posted: August 8, 2017
• Study Start: July 20, 2017
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-03

Locations

IR (1)