NCT Number: NCT07499791
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Beijing Tongren Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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).
Other names: Absorbable Lacrimal Sac Steroid-Eluting Stent, LN1509, LN1209, LN0907
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.
Other names: Budesonide Nasal Spray
Time frame: 3 months postoperatively
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
Assessment: endoscopic confirmation of epithelialized, patent ostium.
Time frame: During surgery
Duration of surgery measured from incision to closure, reported in minutes.
Time frame: During surgery
Volume of blood loss during surgery, reported in milliliters (mL).
Time frame: Postoperative hospitalization (within 1 week)
Number of days from surgery to hospital discharge.
Time frame: 3 months, 6 months, and 12 months
Definition: recurrence of tearing with obstruction confirmed by irrigation.
Time frame: 12 months
Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied <60).
Contact information is provided by the study sponsor or research team.
Beijing Tongren Hospital
Other
A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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