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

Phase 2

• Conditions: Congenital Nasolacrimal Duct Obstruction
• Interventions: Procedure: Endodiathermy Probe and Intubation Versus Intubation

• Registration Number: NCT04148170
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-01
• Study Start: 2020-03
• Primary Completion: 2020-06
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
classic intubation	Endodiathermy Probe and Intubation Versus Intubation	children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.
endodiathermy probe	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

Primary Outcome Measures

Name	Time	Method
recanalization of nasolacrimal duct	6 months	compare the efficiency of endodiathermy probe followed by intubation versus probing with metal probe followed by intubation by; 1. epiphora (overflow of tears onto the face); 2. increase tear film meniscus ( more than 1mm in height); 3. mucous discharge; 4. Fluorescein disappearance test (Normally, little or no dye remains after 5 minutes. Prolonged retention is indicative of inadequate lacrimal drainage)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abo El Resh Pedriatric Hospital Cairo University; 🇪🇬 Cairo, Egypt