CompletedNot Applicable

Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children

France108 participantsStarted 2015-09-02

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nasal hemorrhage

Timeframe: Through surgery completion, an average of 1 hour

Trial details

NCT IDNCT02851641

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2019-09-11

View on ClinicalTrials.gov More Lacrimal Duct Obstruction trials