Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

Phase 3

Recruiting

• Conditions: Chalazion
• Interventions: Procedure: Incision and Curettage; Drug: 5-fluorouracil Injection; Drug: Triamcinolone Acetonide; Drug: Triamcinolone Acetonide/5-fluorouracil mixture

• Registration Number: NCT02025023
• Lead Sponsor: University of Washington

Brief Summary

Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

Detailed Description

This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-29
• Study First Submitted QC: 2013-12-29
• Study First Posted: 2013-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Single or multiple chalazia in a single eyelid

Exclusion Criteria

• Chalazia present for less than one month and no previous injection or incision and curettage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Incision and Curettage	Incision and Curettage	A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.
Injection of Triamcinolone Acetonide	Incision and Curettage	0.1 ml of triamcinolone is injected directly in the chalazion.
Injection of 5-fluorouracil	5-fluorouracil Injection	0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
Injection of 5-fluorouracil	Incision and Curettage	0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
Injection of triamcinolone/5FU mixture	Incision and Curettage	0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.
Injection of triamcinolone/5FU mixture	Triamcinolone Acetonide/5-fluorouracil mixture	0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.
Injection of Triamcinolone Acetonide	Triamcinolone Acetonide	0.1 ml of triamcinolone is injected directly in the chalazion.

Primary Outcome Measures

Name	Time	Method
Size of chalazion	4 weeks

Trial Locations

Locations (1)

University of Washington Eye Institute at Harborview; 🇺🇸 Seattle, Washington, United States