Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Absorbable 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).
• Препарат Conventional 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.

Первичные конечные точки

• Total Clinical Effectiveness Rate at 3 Months [Срок оценки: 3 months postoperatively]
• Lacrimal Ostium Formation Rate at 3 Months [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Operation Time [Срок оценки: During surgery]
• Intraoperative Blood Loss [Срок оценки: During surgery]
• Length of Hospital Stay [Срок оценки: Postoperative hospitalization (within 1 week)]
• Recurrence Rate [Срок оценки: 3 months, 6 months, and 12 months]
• Patient Satisfaction Score [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000 — Пекин

Идентификаторы

NCT: NCT07499791 · LN-DCR-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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