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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04148170

Enrollment

Registered

2019-11-01

Start date

2020-03-31

Completion date

2020-09-30

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Nasolacrimal Duct Obstruction

Keywords

Endodiathermy Probe and Intubation Versus Intubation Only

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

Interventions

PROCEDUREEndodiathermy 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

2 Years to 7 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Contacts

Primary Contactmohamed hafez ibrahim

monsieur84@yahoo.com00201224010523

Backup Contactkarim elessawy

kemos1984@yahoo.com00201144008882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026