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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chalazion

Intervention / Treatment
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* Drug: 5-fluorouracil Injection
* Drug: Triamcinolone Acetonide
* Procedure: Incision and Curettage
* Drug: Triamcinolone Acetonide/5-fluorouracil mixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Incision and Curettage<br>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<br>* 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.<br>|
| Active Comparator: Injection of Triamcinolone Acetonide<br>0.1 ml of triamcinolone is injected directly in the chalazion. | Drug: Triamcinolone Acetonide<br>* If chalazion present at follow-up, another Triamcinolone injection will be done.<br>* Other names: triamcinolone;Procedure: Incision and Curettage<br>* 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.<br>|
| Active Comparator: Injection of 5-fluorouracil<br>0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally. | Drug: 5-fluorouracil Injection<br>* If the chalazion is present at follow-up visit, another injection of 5-FU will be given.<br>* Other names: 5-FU;Procedure: Incision and Curettage<br>* 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.<br>|
| Active Comparator: Injection of triamcinolone/5FU mixture<br>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<br>* 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.<br>Drug: Triamcinolone Acetonide/5-fluorouracil mixture<br>* If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of chalazion |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Size, Pain, Resolution, Complications, Swelling