A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Tongren Hospital
RECRUITING
Beijing
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Participants undergo endoscopic dacryocystorhinostomy (E-DCR) with implantation of an absorbable lacrimal sac drug-eluting stent (LN1509, LN1209, or LN0907; PuYi Biotech, Shanghai). The stent provides mechanical separation and sustained local release of mometasone furoate. Postoperatively, all participants receive systemic antibiotics for 1-3 days and topical low-dose corticosteroid and antibiotic eye drops for approximately 2 weeks. Nasal endoscopy and lacrimal irrigation are performed at 1 week, 2 weeks, 1 month, 2 months, and 3 months post-surgery. Granulation tissue is removed as necessary to maintain ostium patency.
Placebo_comparator: Standard E-DCR with Conventional Packing
Participants undergo standard endoscopic dacryocystorhinostomy (E-DCR) without a stent. The ostium is packed with conventional materials. Postoperatively, participants receive the same systemic antibiotics and topical eye drops as the experimental group. Additionally, they use budesonide nasal spray (2 sprays/day) for 3 months. Nasal endoscopy and lacrimal irrigation follow the same schedule as the experimental group, with granulation tissue removed as needed.