Adding 5‑Fluorouracil to endoscopic DCR for blocked tear ducts with a small lacrimal sac

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled interventional study comparing endoscopic dacryocystorhinostomy (En‑DCR) with intraoperative 5‑fluorouracil versus saline in adults who have primary acquired nasolacrimal duct obstruction with a small lacrimal sac. Eligible patients are randomized to receive either 5‑fluorouracil or saline as an adjuvant during En‑DCR, with standardized surgical technique and follow‑up visits at the study center. Outcomes will focus on postoperative surgical success, lacrimal drainage patency, symptom relief, and complication rates. The trial is conducted at a single tertiary ophthalmology center with preoperative imaging used to define the small sac subtype (≤3 mm).

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Ophthalmic Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xuanwei Liang
• Email: liangxuanwei@163.com
• Phone: +8613694220662

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Four- versus two-point balloon dacryoplasty for blocked tear ducts

  This will see if using four inflation points instead of two during balloon dacryoplasty helps people with primary acquired nasolacrimal duct obstruction get better tear drainage.

  Recruiting National Taiwan University Hospital · Taipei · NCT07225244

• Using artificial tears to prevent tear duct blockage after thyroid cancer treatment

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.