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

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Congenital Nasolacrimal Duct Obstruction

Treatments: Procedure: Endodiathermy Probe and Intubation Versus Intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT04148170

Cairo118988

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

classic intubation

Active Comparator group

Description:

children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.

Treatment:

Procedure: Endodiathermy Probe and Intubation Versus Intubation

endodiathermy probe

Active Comparator group

Description:

children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Treatment:

Procedure: Endodiathermy Probe and Intubation Versus Intubation