NCT02851641

Brief Summary

The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO). In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes. A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

4 years

First QC Date

July 28, 2016

Last Update Submit

December 10, 2019

Conditions

Lacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

  • Nasal hemorrhage

    Through surgery completion, an average of 1 hour

Study Arms (1)

Nasolacrimal duct obstruction

Procedure: "pushed" mono-canaliculonasal intubation

Interventions

"pushed" mono-canaliculonasal intubationPROCEDURE
Nasolacrimal duct obstruction

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with congenital nasolacrimal duct obstruction

You may qualify if:

  • \< 6 years of age
  • Unilateral lacrimal duct obstruction with programmed surgery
  • Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
  • No opposition of parents for he participation of their child

You may not qualify if:

  • Coagulation disorder
  • Previous history of nasolacrimal intubation (homo or contra-lateral)
  • Non covered by health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 1, 2016

Study Start

September 2, 2015

Primary Completion

September 11, 2019

Study Completion

December 10, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

FR(1)