NCT00690768已完成2 期
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- amount of intraoperative intra-ocular bleeding
研究概览
简要总结
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
排除标准
- •Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- •Previous intra-ocular surgery other than cataract surgery
- •Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- •Prothrombin time, partial thromboplastin time or platelet count without normal limits
- •History of previous thromboembolic events
研究组 & 干预措施
A
Experimental
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
干预措施: Bevacizumab (Drug)
A
Experimental
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
干预措施: pars plana vitrectomy (Procedure)
B
Active Comparator
Pars plana vitrectomy only
干预措施: pars plana vitrectomy (Procedure)
结局指标
主要结局
amount of intraoperative intra-ocular bleeding
时间窗: three weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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