NCT01201161已完成2 期
The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment
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
- 19
- 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 was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
RANI/PPV
Experimental
Preoperative intravitreal ranibizumab and pars plana vitrectomy
干预措施: Ranibizumab (Drug)
PPV
Placebo Comparator
Sham injection and pars plana vitrectomy
干预措施: Sham injection (Other)
结局指标
主要结局
amount of intraoperative intra-ocular bleeding
时间窗: one week
amount of intra-ocular bleeding that occurred during pars plana vitrectomy
次要结局
- visual acuity(12 weeks)
研究者
研究点 (1)
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