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Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

RecruitingPhase 2Ages 18 Years - 65 YearsAllBeijing Tongren Hospital
NCT07499791 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. The stent is composed of absorbable polymer mesh coated with mometasone furoate to reduce postoperative inflammation and adhesion, maintain ostium patency, and improve surgical outcomes. A total of 40 patients will be randomized 1:1 to receive either the absorbable stent or conventional packing with routine postoperative intranasal budesonide therapy.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed chronic dacryocystitis History of failed E-DCR or lacrimal intubation Preoperative dacryocystography showing lacrimal sac diameter ≥4 mm Age ≥18 years Able to consent and comply with procedures Exclusion Criteria: * Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis Lacrimal sac non-visualization on imaging Lacrimal sac rupture, traumatic duct/bone injuries Allergy to mometasone furoate or PLA/PGA polymers Poor general health, unable to tolerate surgery Psychiatric disorders or antipsychotic drug use Uncontrolled hypertension, diabetes, or severe systemic diseases Keloid tendency Coagulation disorders Pregnancy
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What it tests

  • Absorbable Lacrimal Sac Drug-Eluting Stent
  • Conventional Ostium Packing with Budesonide Nasal Spray
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Where

2 sites
Beijing Tongren Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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