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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
2026-08-27
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 (2)
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China