CompletedNot Applicable

External Versus Powered Endoscopic Dacryocystorhinostomy With Mitomycin C for Primary Acquired Nasolacrimal Duct Obstruction

Poland60 participantsStarted 2023-07-18

Plain-language summary

Primary acquired nasolacrimal duct obstruction causes persistent tearing because tears cannot drain normally from the eye into the nose. The purpose of this randomized study was to compare two operations used to restore tear drainage: external dacryocystorhinostomy, performed through a small skin incision near the inner corner of the eye, and powered endoscopic dacryocystorhinostomy, performed through the nose using an endoscope and powered instruments, with mitomycin C applied during surgery to reduce scar formation. Participants were assigned to the two surgical groups using a pre-generated randomization list. Recruitment was completed after 60 participants had been enrolled, resulting in 30 participants in each group. Participants were followed for 12 months after surgery. The main outcomes were whether the newly created tear drainage opening remained open and whether tearing symptoms improved. Additional assessments included postoperative symptom severity, patient satisfaction, surgical complications, cosmetic concerns related to the external scar, and willingness to undergo the same procedure again.

Who can participate

Age range

18 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: * Age 18 years or older. * Unilateral or bilateral pathological epiphora not expected to improve with conservative treatment. * Confirmed primary acquired obstruction at the level of the lacrimal sac or nasolacrimal duct, with an indication for dacryocystorhinostomy. * General health status permitting surgery under general anesthesia and participation in the 12-month follow-up. * Ability to understand the study requirements and comply with the scheduled study procedures and follow-up visits. * Written informed consent to participate in the study and undergo surgery. Exclusion Criteria: * History of previous lacrimal drainage surgery, including external, endoscopic, or laser-assisted dacryocystorhinostomy. * Acute inflammation or infection of the lacrimal drainage system, nasal cavity, or paranasal sinuses. * Suspected neoplastic lesion of the lacrimal drainage system, nasal cavity, or paranasal sinuses. * Clinically significant abnormalities of the eyelids or ocular adnexa that could contribute to epiphora. * History of eyelid surgery. * Documented hypersensitivity to mitomycin C or any medication used during the preoperative, intraoperative, or postoperative procedures. * Cognitive impairment, psychiatric disorder, or emotional instability preventing valid informed consent or adherence to the study procedures. * Inability or unwillingness to comply with the scheduled examinations and follow-up visits. * General medical condition precluding surgery unde…

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

Anatomical Patency of the Rhinostomy

Timeframe: 12 months after surgery

Epiphora Severity Assessed by the Munk Score

Timeframe: 12 months after surgery

Trial details

NCT IDNCT07754058

SponsorMilitary Institute od Medicine National Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-12

View on ClinicalTrials.gov More Primary Acquired Nasolacrimal Duct Obstruction trials