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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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).
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.
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China
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%.
Time frame: 3 months postoperatively
Lacrimal Ostium Formation Rate at 3 Months
Assessment: endoscopic confirmation of epithelialized, patent ostium.
Time frame: 3 months
Operation Time
Duration of surgery measured from incision to closure, reported in minutes.
Time frame: During surgery
Intraoperative Blood Loss
Volume of blood loss during surgery, reported in milliliters (mL).
Time frame: During surgery
Length of Hospital Stay
Number of days from surgery to hospital discharge.
Time frame: Postoperative hospitalization (within 1 week)
Recurrence Rate
Definition: recurrence of tearing with obstruction confirmed by irrigation.
Time frame: 3 months, 6 months, and 12 months
Patient Satisfaction Score
Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied \<60).
Time frame: 12 months
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