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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable Lacrimal Sac Drug-Eluting Stent | Experimental | 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. |
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| Standard E-DCR with Conventional Packing | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absorbable Lacrimal Sac Drug-Eluting Stent | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operation Time | Duration of surgery measured from incision to closure, reported in minutes. | During surgery |
| Intraoperative Blood Loss | Volume of blood loss during surgery, reported in milliliters (mL). |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengshuo wang | Contact | 86-13911623569 | wangcs830@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chengshuo Wang | Beijing Tongren Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000 | Beijing | China |
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| Conventional Ostium Packing with Budesonide Nasal Spray | Drug | 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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| During surgery |
| Length of Hospital Stay | Number of days from surgery to hospital discharge. | Postoperative hospitalization (within 1 week) |
| Recurrence Rate | Definition: recurrence of tearing with obstruction confirmed by irrigation. | 3 months, 6 months, and 12 months |
| Patient Satisfaction Score | Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied <60). | 12 months |