UnknownNot Applicable

Endoscopy Assisted Probing Versus Simple Probing in Primary Congenital Nasolacrimal Duct Obstruction

Iran320 participantsStarted 2017-07-20

Plain-language summary

The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with the standard simple probing in cases with congenital nasolacrimal duct obstruction . Furthermore, investigators will identify associated anatomical anomalies. Investigators believe results of this study can be valuable in better understanding of this disease and provide a high evidence level necessary to propose a classification and management algorithm. Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction, no past surgical management, with one or more of the below criteria will be included: 1. Non-resolving symptoms of epiphora and/or discharge. 2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical antibiotics. 3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and patients will undergo lacrimal tests before and after operation in one week, one month and 3months based on a special record form. Patients will be randomly assigned to "simple probing" group or "endoscopy assisted probing" group. All operations will be performed in operative theater and under general anesthesia. Pre- and post-operative examinations will be performed in plastic clinic in Farabi hospital.

Who can participate

Age range

3 Weeks – 6 Years

Sex

ALL

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

Inclusion criteria

. age: 3 weeks\<Age\<6 years
. epiphora or discharge since birth or within 8 weeks after birth

Exclusion criteria

. Follow up less than 3 months
. Epiphora secondary to etiologies than congenital naso-lacrimal duct obstruction such as puncta/canalicular aplasia/dysgenesis;midfacial anomalies; congenital eyelid malposition;epiblepharon; trichiasis; congenital glaucoma, tumors; blepharitis; trauma Treatment success: defined success absence of epiphora/lacrimation and discharge 6 months after intervention.

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

success rate

Timeframe: 6 months

Trial details

NCT IDNCT03242681

SponsorTehran University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-01

View on ClinicalTrials.gov More Congenital Nasolacrimal Duct Obstruction trials