Health TrialsbyHealthPanel

Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

ConditionChronic Dacryocystitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tongren Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosed chronic dacryocystitis

Disqualifiers

Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Absorbable Lacrimal Sac Drug-Eluting Stent

    Device

    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).

  • Conventional Ostium Packing with Budesonide Nasal Spray

    Drug

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Absorbable Lacrimal Sac Drug-Eluting StentExperimental treatment 1 intervention
Group B: Standard E-DCR with Conventional PackingPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Clinical Effectiveness Rate at 3 Months

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 postoperatively
2

Lacrimal Ostium Formation Rate at 3 Months

Assessment: endoscopic confirmation of epithelialized, patent ostium.

Time frame
3 months

Secondary outcomes

1

Operation Time

Duration of surgery measured from incision to closure, reported in minutes.

Time frame
During surgery
2

Intraoperative Blood Loss

Volume of blood loss during surgery, reported in milliliters (mL).

Time frame
During surgery
3

Length of Hospital Stay

Number of days from surgery to hospital discharge.

Time frame
Postoperative hospitalization (within 1 week)
4

Recurrence Rate

Definition: recurrence of tearing with obstruction confirmed by irrigation.

Time frame
3 months, 6 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tongren Hospital

Lead sponsor

Source ClinicalTrials.gov
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