Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

Capital Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Dacryocystitis

Treatments: Device: Absorbable Lacrimal Sac Drug-Eluting Stent; Drug: Conventional Ostium Packing with Budesonide Nasal Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT07499791

LN-DCR-2025

Details and patient eligibility

About

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.

Full description

This is a prospective, multicenter, randomized, parallel-controlled clinical trial conducted to assess the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent in patients with recurrent chronic dacryocystitis undergoing endoscopic endonasal dacryocystorhinostomy (E-DCR).

Eligible patients diagnosed with recurrent chronic dacryocystitis and meeting the inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive implantation of an absorbable polymer mesh stent coated with mometasone furoate at the osteotomy site during E-DCR. Patients in the control group will undergo E-DCR with conventional packing, followed by routine postoperative intranasal budesonide therapy.

The absorbable drug-eluting stent is designed to locally release mometasone furoate to reduce postoperative inflammation and adhesion formation, thereby maintaining ostium patency and promoting mucosal healing. Patients will be followed postoperatively according to the study protocol, with scheduled assessments of clinical effectiveness, ostium formation, surgical indicators, recurrence, and patient satisfaction at predefined time points. Safety outcomes will include the incidence of procedure- or device-related adverse events throughout the follow-up period.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis

Lacrimal sac non-visualization on imaging

Lacrimal sac rupture, traumatic duct/bone injuries

Allergy to mometasone furoate or PLA/PGA polymers

Poor general health, unable to tolerate surgery

Psychiatric disorders or antipsychotic drug use

Uncontrolled hypertension, diabetes, or severe systemic diseases

Keloid tendency

Coagulation disorders

Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Absorbable Lacrimal Sac Drug-Eluting Stent

Experimental group

Description:

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.

Treatment:

Device: Absorbable Lacrimal Sac Drug-Eluting Stent

Standard E-DCR with Conventional Packing

Placebo Comparator group

Description:

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.

Treatment:

Drug: Conventional Ostium Packing with Budesonide Nasal Spray