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Chalazia Treatment Study (CTS)

This study is currently recruiting participants.
Verified May 2017 by Shu-Hong Chang, University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT02025023
First Posted: December 31, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shu-Hong Chang, University of Washington
  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 Intervention Phase
Chalazion Drug: 5-fluorouracil Injection Drug: Triamcinolone Acetonide Procedure: Incision and Curettage Drug: Triamcinolone Acetonide/5-fluorouracil mixture Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

Resource links provided by NLM:


Further study details as provided by Shu-Hong Chang, University of Washington:

Primary Outcome Measures:
  • Size of chalazion [ Time Frame: 4 weeks ]

Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025023


Contacts
Contact: Shu-Hong Chang, MD 206-744-2020 shuchang@uw.edu
Contact: Sue Rath, COT 206-897-4331 raths@uw.edu

Locations
United States, Washington
University of Washington Eye Institute at Harborview Recruiting
Seattle, Washington, United States, 98104
Contact: Sue Rath, COT    206-897-4331    raths@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Shu-Hong Chang, MD University of Washington Eye Institute
  More Information

Responsible Party: Shu-Hong Chang, Assistant Professor of Ophthalmology, University of Washington
ClinicalTrials.gov Identifier: NCT02025023     History of Changes
Other Study ID Numbers: 42336
First Submitted: December 29, 2013
First Posted: December 31, 2013
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Shu-Hong Chang, University of Washington:
Size
Pain
Resolution
Complications
Swelling

Additional relevant MeSH terms:
Eyelid Diseases
Chalazion
Cysts
Neoplasms
Eye Diseases
Fluorouracil
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors