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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Congenital Nasolacrimal Duct Obstruction

Intervention / Treatment
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* Procedure: Endodiathermy Probe and Intubation Versus Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children in the age group above 2 years old No history of previous probing. No history of previous intubation. Children with no any other association or congenital anomalies cause watery eye. children suffer from congenital nasolacrimal duct obstruction. Exclusion Criteria: children less than 2 years old. previous probing. previous intubation. children with any other congenital anomalies as congenital ectropion , congenital entropion children suffer from any upper lacrimal anomalies as obstruction or stenosis.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classic intubation<br>children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube. | Procedure: Endodiathermy Probe and Intubation Versus Intubation<br>* children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube<br>|
| Active Comparator: endodiathermy probe<br>children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube | Procedure: Endodiathermy Probe and Intubation Versus Intubation<br>* children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recanalization of nasolacrimal duct | 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodiathermy Probe and Intubation Versus Intubation Only