A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
Sponsor study identifier
interventional
40
1 country
2
Study Start
May 1, 2026
Actual (reported)Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2025
Actual (reported)March 30, 2026
Actual (reported)May 1, 2026
Actual (reported)December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Total Clinical Effectiveness Rate at 3 Months
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%.
3 months postoperatively
Lacrimal Ostium Formation Rate at 3 Months
Assessment: endoscopic confirmation of epithelialized, patent ostium.
3 months
Operation Time
During surgery
Intraoperative Blood Loss
During surgery
Length of Hospital Stay
Postoperative hospitalization (within 1 week)
Recurrence Rate
3 months, 6 months, and 12 months
Patient Satisfaction Score
12 months
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.
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.
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).
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China
Chengshuo Wang
Beijing Tongren Hospital
First Submitted
December 27, 2025
First Posted
March 30, 2026
Study Start
May 1, 2026
Actual (reported)Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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Study Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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