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NCT Number: NCT07499791

Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

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.

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Key information

Conditions

Chronic Dacryocystitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000

Beijing, China

Location contact

chengshuo wang

CONTACT

[email protected]

+86-13911623569

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Absorbable Lacrimal Sac Steroid-Eluting Stent, LN1509, LN1209, LN0907

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.

Other names: Budesonide Nasal Spray

Primary outcomes

  1. Total Clinical Effectiveness Rate at 3 Months

    Time frame: 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%.

  2. Lacrimal Ostium Formation Rate at 3 Months

    Time frame: 3 months

    Assessment: endoscopic confirmation of epithelialized, patent ostium.

Secondary outcomes

  1. Operation Time

    Time frame: During surgery

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

  2. Intraoperative Blood Loss

    Time frame: During surgery

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

  3. Length of Hospital Stay

    Time frame: Postoperative hospitalization (within 1 week)

    Number of days from surgery to hospital discharge.

  4. Recurrence Rate

    Time frame: 3 months, 6 months, and 12 months

    Definition: recurrence of tearing with obstruction confirmed by irrigation.

  5. Patient Satisfaction Score

    Time frame: 12 months

    Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied <60).

Study contacts

Contact information is provided by the study sponsor or research team.

Chengshuo wang

CONTACT

[email protected]

86-13911623569

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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