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临床试验/NCT02025023
NCT02025023招募中3 期

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

University of Washington1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
120
试验地点
1
主要终点
Size of chalazion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single or multiple chalazia in a single eyelid

排除标准

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

研究组 & 干预措施

Incision and Curettage

Active Comparator

A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.

干预措施: Incision and Curettage (Procedure)

Injection of Triamcinolone Acetonide

Active Comparator

0.1 ml of triamcinolone is injected directly in the chalazion.

干预措施: Triamcinolone Acetonide (Drug)

Injection of Triamcinolone Acetonide

Active Comparator

0.1 ml of triamcinolone is injected directly in the chalazion.

干预措施: Incision and Curettage (Procedure)

Injection of 5-fluorouracil

Active Comparator

0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.

干预措施: 5-fluorouracil Injection (Drug)

Injection of 5-fluorouracil

Active Comparator

0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.

干预措施: Incision and Curettage (Procedure)

Injection of triamcinolone/5FU mixture

Active Comparator

0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.

干预措施: Incision and Curettage (Procedure)

Injection of triamcinolone/5FU mixture

Active Comparator

0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.

干预措施: Triamcinolone Acetonide/5-fluorouracil mixture (Drug)

结局指标

主要结局

Size of chalazion

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Zhang

Assistant Professor of Ophthalmology

University of Washington

研究点 (1)

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