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Recruiting
NCT07499791
Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
Conditions: Chronic Dacryocystitis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: Beijing Tongren Hospital
Location: Beijing Tongren Hospital Beijing Beijing Municipality
Summary
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.
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
Source: ClinicalTrials.gov (NCT07499791). StuddyBuddy aggregates publicly available trial information.