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Efficacy Evaluation of 5-Fluorouracil as an Adjuvant to Endoscopic Dacryocystorhinostomy in Managing Primary Acquired Nasolacrimal Duct Obstruction With Small Lacrimal Sac: A Randomized Controlled Study

RecruitingNAAges 18 Years - anyAllZhongshan Ophthalmic Center, Sun Yat-sen Universi…
NCT07154121 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary acquired nasolacrimal duct obstruction (PANDO) is a lacrimal duct obstruction disease characterized by inflammatory fibrosis of the nasolacrimal duct, with primary symptoms including epiphora and increased secretions, commonly seen in middle-aged and elderly women over 40 years of age . The pathogenesis of PANDO remains unclear, and there are no effective pharmacological treatments. Dacryocystorhinostomy (DCR) is currently considered the primary treatment for PANDO, as it restores tear drainage by creating an alternative drainage pathway between the lacrimal sac and the nasal cavity. The surgical techniques for DCR primarily include external DCR (Ex-DCR) and endoscopic DCR (En-DCR), with En-DCR first proposed by McDonogh and Meiring in 1989. In recent years, with the advancement of endoscopic sinus surgery techniques, En-DCR has gained widespread recognition in the treatment of

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients diagnosed with small lacrimal sac-type PANDO based on clinical symptoms, lacrimal duct irrigation, and CT lacrimal duct angiography (minimum diameter on lacrimal sac angiography ≤3 mm); 2. Patients aged 18 years or older; 3. Patients with no history of drug allergies (including 5-FU, contrast agents, or other substances that may affect participation in this study); 4. Patients who have provided informed consent and signed the informed consent form. Exclusion Criteria: 1. Previously underwent nasolacrimal duct surgery; 2. Nasolacrimal duct obstruction secondary to facial surgery, sinus disease, tumors, trauma, or revision DCR; 3. Severe sinusitis or deviated nasal septum; 4. Acute dacryocystitis; 5. Patients with chronic debilitating conditions such as diabetes, malignant tumors, or malnutrition; 6. Patients with systemic diseases such as sarcoidosis or Wegener's granulomatosis that may promote scar formation.
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What it tests

  • 5-fluorouracil group
  • saline group
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Where

1 site
Zhongshan Ophthalmic Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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