Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- early post-vitrectomy vitreous hemorrhage
研究概览
简要总结
The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.
详细描述
Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR
排除标准
- •One eye patient
- •Best corrected visual acuity better than 20/50
- •Pregnancy
- •Use of internal tamponade such as silicone oil during surgery
- •Concurrent ophthalmic surgery such as cataract extraction
研究组 & 干预措施
1
Intravitreal bevacizumab injection 1-2 weeks before surgery
干预措施: Bevacizumab (Drug)
2
Sham injection (needleless syringe pressed against conjunctiva)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
early post-vitrectomy vitreous hemorrhage
次要结局
- Visual improvement