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

Primary Purpose

Congenital Nasolacrimal Duct Obstruction

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Endodiathermy Probe and Intubation Versus Intubation

About this trial

This is an interventional treatment trial for Congenital Nasolacrimal Duct Obstruction focused on measuring Endodiathermy Probe and Intubation Versus Intubation Only

Eligibility Criteria

2 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Abo El Resh Pedriatric Hospital Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

classic intubation

endodiathermy probe

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

complication

Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure.

Full Information

NCT ID

NCT04148170

First Posted

October 27, 2019

Last Updated

October 30, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04148170

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2020 (Anticipated)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Nasolacrimal Duct Obstruction

Keywords

Endodiathermy Probe and Intubation Versus Intubation Only

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

Participant

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

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

classic intubation

Arm Type

Active Comparator

Arm Description

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

Arm Title

endodiathermy probe

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endodiathermy Probe and Intubation Versus Intubation

Intervention Description

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

Primary Outcome Measure Information:

Title

recanalization of nasolacrimal duct

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

complication

Description

Record any complication in two procedures as tube migration, tube extrusion, infection or need for additional procedure.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mohamed hafez ibrahim

Phone

00201224010523

monsieur84@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

karim elessawy

Phone

00201144008882

kemos1984@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

tamer gawdat, professor

Organizational Affiliation

professor of ophthalmology cairo university

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abo El Resh Pedriatric Hospital Cairo University

City

Cairo

ZIP/Postal Code

31111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

karim bakr, lecture

Phone

00201144008882

kemos1984@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

after finishiny my research can share my data

IPD Sharing Time Frame

1 year untill 1 year and 6 months

IPD Sharing Access Criteria

after finish my study

Citations:

PubMed Identifier

25370408

Citation

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.

Results Reference

result

Learn more about this trial

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

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