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

Plain-language summary

This study compares the addition of 5-Fluorouracil (5-FU) versus saline to endoscopic dacryocystorhinostomy surgery in patients with small lacrimal sac primary acquired nasolacrimal duct obstruction (blockage of the tear duct). Patients aged 18 and older with this diagnosis may take part. This is a study without a clinical phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Intervention

5-fluorouracil group, saline group

Start date

9/8/2025

Estimated completion

7/1/2026

Countries

China

Related genes

Locations

• Guangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.