Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only

Overview

The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2020

Detailed Description

The study will be conducted on children above 2 year and will be divided randomly into two groups: Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Interventions

  • Procedure: Endodiathermy Probe and Intubation Versus Intubation
    • children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Arms, Groups and Cohorts

  • Active Comparator: classic intubation
    • children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
  • Active Comparator: endodiathermy probe
    • children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Clinical Trial Outcome Measures

Primary Measures

  • recanalization of nasolacrimal duct
    • Time Frame: 6 months
    • compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by epiphora (overflow of tears onto the face) increase tear film meniscus ( more than 1mm in height) mucous discharge Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)

Secondary Measures

  • complication
    • Time Frame: 6 months
    • Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure.

Participating in This Clinical Trial

Inclusion Criteria

1. Children in the age group above 2 years old 2. No history of previous probing. 3. No history of previous intubation. 4. Children with no any other association or congenital anomalies cause watery eye. 5. children suffer from congenital nasolacrimal duct obstruction. Exclusion Criteria:

1. children less than 2 years old. 2. previous probing. 3. previous intubation. 4. children with any other congenital anomalies as congenital ectropion , congenital entropion 5. children suffer from any upper lacrimal anomalies as obstruction or stenosis.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sameh Hassan Abdelbaky, Assistant Professor of Ophthalmology. – Cairo University
  • Overall Official(s)
    • tamer gawdat, professor, Principal Investigator, professor of ophthalmology cairo university
  • Overall Contact(s)
    • mohamed hafez ibrahim, 00201224010523, monsieur84@yahoo.com

Citations Reporting on Results

Suranagi PV, Poornima MS; Smruthi; Banagar B. Regarding a novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe. Indian J Ophthalmol. 2014 Sep;62(9):971. doi: 10.4103/0301-4738.143956. No abstract available.

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