Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Absorbable Lacrimal Sac Drug-Eluting Stent: 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: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Total Clinical Effectiveness Rate at 3 Months — 3 months postoperatively
  Based on symptom resolution and lacrimal irrigation: Cured: complete symptom resolution and patent irrigation Effective: mild tearing, patent or pressurized irrigation Ineffective: persistent tearing or obstruction Total effectiveness = (cured + effective cases) / total × 100%.
• Lacrimal Ostium Formation Rate at 3 Months — 3 months
  Assessment: endoscopic confirmation of epithelialized, patent ostium.

Trial sites (2)

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