RECRUITING Phase 2 ClinicalTrials.gov

Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

Sponsor: Beijing Tongren Hospital • ClinicalTrials.gov ID: NCT07499791

Registry updated: 2026-08-27

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Description

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.

Interventions

Absorbable Lacrimal Sac Drug-Eluting Stent (Device)
During E-DCR, the stent is implanted at the osteotomy site to provide mechanical separation and local release of mometasone furoate. The polymer scaffold is fully absorbable. Available models: LN1509 (15×9 mm), LN1209 (12×9 mm), LN0907 (9×7 mm).
Conventional Ostium Packing with Budesonide Nasal Spray (Drug)
After standard E-DCR, the ostium is packed with conventional materials. Postoperatively, participants use budesonide nasal spray (2 sprays/day) for 3 months. All other postoperative care is the same as in the experimental group.

Eligibility criteria

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

Conditions

Chronic Dacryocystitis

Locations

Beijing Tongren Hospital — Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000 — Beijing, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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