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

Congenital Nasolacrimal Duct Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04148170
• Other study ID #: Cairo118988
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 2020
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: mohamed hafez ibrahim
• Phone: 00201224010523
• Email: monsieur84[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Nasolacrimal Duct Obstruction

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Abo El Resh Pedriatric Hospital Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Suranagi PV, Poornima MS; Smruthi, Banagar B. Regarding a novel technique to recanalize the nasolacrimal duct with endodiathermy bipolar probe. Indian J Ophthalmol. 2014 Sep;62(9):971. doi: 10.4103/0301-4738.143956. — View Citation

Outcome

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