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

NCT04148170 | Unknown Phase 2 DMC

• 1 other identifier: Cairo118988
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Nasolacrimal Duct Obstruction

Keywords

Endodiathermy Probe and Intubation Versus Intubation Only

Outcome Measures

Primary Outcomes (1)

• recanalization of nasolacrimal duct

  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)

  6 months

Secondary Outcomes (1)

• complication

  6 months

Study Arms (2)

classic intubation

ACTIVE COMPARATOR

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

Procedure: Endodiathermy Probe and Intubation Versus Intubation

endodiathermy probe

ACTIVE COMPARATOR

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

Procedure: Endodiathermy Probe and Intubation Versus Intubation

Interventions

Endodiathermy Probe and Intubation Versus Intubation PROCEDURE

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

classic intubation; endodiathermy probe

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children in the age group above 2 years old
• No history of previous probing.
• No history of previous intubation.
• Children with no any other association or congenital anomalies cause watery eye.
• children suffer from congenital nasolacrimal duct obstruction.

You may not qualify if:

• children less than 2 years old.
• previous probing.
• previous intubation.
• children with any other congenital anomalies as congenital ectropion , congenital entropion
• children suffer from any upper lacrimal anomalies as obstruction or stenosis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abo El Resh Pedriatric Hospital Cairo University

Cairo, 31111, Egypt

RECRUITING

Related 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. No abstract available.

  PMID: 25370408 RESULT

Study Officials

• tamer gawdat, professor

  professor of ophthalmology cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed hafez ibrahim

CONTACT

00201224010523; monsieur84@yahoo.com

karim elessawy

CONTACT

00201144008882; kemos1984@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: all will be know the surgical procedure but participant will know only that he will be treated but cant understand type of procedure done
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology.

Model Details: 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 Record Dates

• First Submitted: October 27, 2019
• First Posted: November 1, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year untill 1 year and 6 months
• Access Criteria: after finish my study

Locations

EG (1)