NCT00370409已完成不适用
Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
研究概览
简要总结
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic retinopathy cases undergoing vitrectomy
排除标准
- •History of deep vitrectomy or cataract surgery
- •Renal failure
- •Silicone oil injection during surgery
- •Early rebleeding
- •History of antithrombotic drugs usage
结局指标
主要结局
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
时间窗: 6 months
次要结局
- Incidence of late vitreous hemorrhage in the cryo group.(6 months)
- Incidence of late vitreous hemorrhage in the control group.(6 months)
- Comparing incidence of late vitreous hemorrhage in both groups.(6 months)
研究者
研究点 (2)
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