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Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
Sponsor: Beijing Tongren Hospital
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.
Official title: A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-05-01
Completion Date
2027-12-01
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China