Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
Starting soon · Phase 2
Conditions studied: Chronic Dacryocystitis
In brief
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.
Key facts
- Study ID
- NCT07499791
- Run by
- Beijing Tongren Hospital
- People needed
- 40
- Starts
- 2026-05-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000 — Beijing, China
Full record on ClinicalTrials.gov
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