Lacrimal Duct Obstruction Clinical Trial
— CANALHEMOVerified date | December 2019 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 10, 2019 |
Est. primary completion date | September 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Years |
Eligibility |
Inclusion Criteria: - < 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 Exclusion Criteria: - Coagulation disorder - Previous history of nasolacrimal intubation (homo or contra-lateral) - Non covered by health insurance |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique A. de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasal hemorrhage | Through surgery completion, an average of 1 hour |
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