Chronic Dacryocystitis
Conditions
Keywords
Chronic Dacryocystitis
Brief 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.
Detailed description
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.
Interventions
DEVICEAbsorbable Lacrimal Sac Drug-Eluting Stent
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).
DRUGConventional Ostium Packing with Budesonide Nasal Spray
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.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Clinical Effectiveness Rate at 3 Months | 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%. |
| Lacrimal Ostium Formation Rate at 3 Months | 3 months | Assessment: endoscopic confirmation of epithelialized, patent ostium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation Time | During surgery | Duration of surgery measured from incision to closure, reported in minutes. |
| Intraoperative Blood Loss | During surgery | Volume of blood loss during surgery, reported in milliliters (mL). |
| Length of Hospital Stay | Postoperative hospitalization (within 1 week) | Number of days from surgery to hospital discharge. |
| Recurrence Rate | 3 months, 6 months, and 12 months | Definition: recurrence of tearing with obstruction confirmed by irrigation. |
| Patient Satisfaction Score | 12 months | Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied \<60). |
Countries
China
Contacts
CONTACTChengshuo wang
STUDY_CHAIRChengshuo Wang
Beijing Tongren Hospital
Outcome results
None listed