Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Absorbable Lacrimal Sac Drug-Eluting Stent, Conventional Ostium Packing with Budesonide Nasal Spray.
- Who it may be relevant to
- Registry conditions: Chronic Dacryocystitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
Overview
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.
Detailed 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.
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.
Primary outcome measures
- Total Clinical Effectiveness Rate at 3 Months [Time frame: 3 months postoperatively]
- Lacrimal Ostium Formation Rate at 3 Months [Time frame: 3 months]
Secondary outcome measures (5)
- Operation Time [Time frame: During surgery]
- Intraoperative Blood Loss [Time frame: During surgery]
- Length of Hospital Stay [Time frame: Postoperative hospitalization (within 1 week)]
- Recurrence Rate [Time frame: 3 months, 6 months, and 12 months]
- Patient Satisfaction Score [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000 — Beijing
Identifiers
NCT: NCT07499791 · LN-DCR-2025