A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
试验速览
- 阶段
- 3 期
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- percentage of corneal pterygium area
研究概览
简要总结
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.
详细描述
To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary pterygium
排除标准
- •previous ocular surgery
研究组 & 干预措施
bevacizumab
intralesional bevacizumab injection
干预措施: Intralesional injection of bevacizumab (Drug)
Topical antihistamine and vasoconstrictor
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
干预措施: Topical antihistamine and vasoconstrictor (Drug)
结局指标
主要结局
percentage of corneal pterygium area
时间窗: 3 years
Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis \[Sony Mavica digital still camera MVC-FD83, Japan\]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table. Number of patients with adverse events will be recorded.
次要结局
未报告次要终点