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

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

This trial will test whether using 5‑fluorouracil during endoscopic dacryocystorhinostomy helps adults with primary acquired nasolacrimal duct obstruction and a small lacrimal sac have better outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07154121 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Adults aged 18 or older with primary acquired nasolacrimal duct obstruction characterized by a small lacrimal sac (≤3 mm on lacrimal sac imaging), no prior nasolacrimal surgery, no relevant drug allergies, and who can give informed consent are the ideal candidates.

Not a fit: Patients with secondary nasolacrimal obstruction (from trauma, tumors, prior surgery, or sinus disease), acute dacryocystitis, severe systemic illness that promotes scarring, or those unable to attend the single study center are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding 5‑fluorouracil could reduce scarring and restenosis after surgery, improving tear drainage and lowering the need for repeat procedures.

How similar studies have performed: Use of anti‑fibrotic agents like 5‑fluorouracil as an adjunct to DCR has been reported in prior small studies with mixed but sometimes favorable results, so this approach has some precedent but is not definitively proven.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xuanwei Liang

Conditions Primary Acquired Nasolacrimal Duct Obstruction