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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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.