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

Purpose

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.

Condition

Chalazion

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator 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.	Procedure: Incision and Curettage If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator Injection of Triamcinolone Acetonide	0.1 ml of triamcinolone is injected directly in the chalazion.	Drug: Triamcinolone Acetonide If chalazion present at follow-up, another Triamcinolone injection will be done. Other names: triamcinolone Procedure: Incision and Curettage If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator Injection of 5-fluorouracil	0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.	Drug: 5-fluorouracil Injection If the chalazion is present at follow-up visit, another injection of 5-FU will be given. Other names: 5-FU Procedure: Incision and Curettage If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator Injection of triamcinolone/5FU mixture	0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.	Procedure: Incision and Curettage If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture. Drug: Triamcinolone Acetonide/5-fluorouracil mixture If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Recruiting Locations

University of Washington Eye Institute at Harborview
Seattle, Washington 98104

Contact:
Simona Vuletic
206-520-9728
simona@uw.edu

More Details

NCT ID: NCT02025023
Status: Recruiting
Sponsor: University of Washington

Study Contact

Simona Vuletic
206-520-9728
simona@uw.edu

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.