Absorbable drug-eluting lacrimal sac stent for recurrent chronic dacryocystitis
Official title: A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy
Run by Beijing Tongren Hospital · NCT07499791 · Data updated 2026-11-12
This study tests whether an absorbable, mometasone-coated lacrimal sac stent placed during a standard endoscopic procedure can help keep the tear duct open and reduce inflammation in people with recurrent chronic dacryocystitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07499791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with recurrent chronic dacryocystitis who have had prior failed E-DCR or lacrimal intubation and meet imaging criteria.
✕Probably not a fit
Patients with severe nasal or systemic conditions or allergy to the stent materials or mometasone may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized phase 2 trial comparing an absorbable drug-eluting lacrimal sac stent to conventional packing after endoscopic endonasal dacryocystorhinostomy (E-DCR) in adults with recurrent chronic dacryocystitis. Participants are randomized 1:1 to receive the stent or usual packing plus postoperative intranasal budesonide. The stent releases mometasone furoate locally to reduce inflammation and adhesions, aiming to maintain ostium patency and improve mucosal healing. Outcomes include safety, ostium formation, surgical indicators, recurrence, and patient satisfaction over predefined follow-up. Eligibility requires a history of failed prior procedures, imaging-confirmed anatomy, and the ability to consent and comply with follow-up.
Why it matters
Potential benefit: If successful, patients may experience better long-term tear duct patency and fewer symptoms after E-DCR.
How similar studies have gone: Prior approaches using drug-eluting or anti-inflammatory strategies in similar nasal-dacryocystorhinostomy settings have shown promising signals, but this exact stent/technique is novel in this indication.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Beijing Tongren Hospital
Beijing, Beijing Municipality, China Recruiting -
Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000
Beijing, China Not yet recruiting
Study contacts
- Study coordinator: Chengshuo wang
- Email: wangcs830@126.com
- Phone: 86-13911623569
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.