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Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

NCT07499791 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-27

No results posted yet for this 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.

Conditions

  • Chronic Dacryocystitis

Interventions

DEVICE

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).

DRUG

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.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Chengshuo Wang · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499791 on ClinicalTrials.gov