A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.
详细描述
Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.
Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.
Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Age: eighteen years old or more
- •IOP: less than 22mmHg
排除标准
- •History of previous ocular surgery
- •Use of topical or systemic corticosteroids for up to a month before the surgery
- •Extensive pterygia that disabled accurate IOP measurement
研究组 & 干预措施
Loteprednol
干预措施: Loteprednol Etabonate 0.5% (Drug)
Dexamethasone
干预措施: Dexamethasone 0.1% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: Once a week for the first 4 weeks and 6 weeks after the procedure
次要结局
- IOP difference between the operated eye and the fellow eye(Once a week for the first 4 weeks and then 6 weeks after the procedure)