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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-09-30

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

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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

Conditions

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Congenital Nasolacrimal Duct Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

all will be know the surgical procedure but participant will know only that he will be treated but cant understand type of procedure done

Study Groups

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classic intubation

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

Group Type ACTIVE_COMPARATOR

Endodiathermy Probe and Intubation Versus Intubation

Intervention Type PROCEDURE

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

endodiathermy probe

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

Group Type ACTIVE_COMPARATOR

Endodiathermy Probe and Intubation Versus Intubation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes