NCT03637283Unknown不适用
Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Mean change from baseline in best-corrected visual acuity (BCVA)
研究概览
简要总结
To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with 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
- 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
- •Age ≥ 18 years old;
- •BRVO is diagnosed
- •Vitreous hemorrhage
- •Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)
排除标准
- •BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
- •BRVO combined with retinal detachment
- •Retinal veins are completely whitened
- •iris neovascularization or neovascular glaucoma
- •Combined glaucoma
- •combined with other retinopathy
- •Received anti-VEGF treatment within 3 months before surgery
研究组 & 干预措施
anti-VEGF
Experimental
vitreoretinal surgery combined with intraoperative anti-VEGF
干预措施: anti-VEGF (Procedure)
fan-shaped photocoagulation
Active Comparator
vitreoretinal surgery combined with fan-shaped photocoagulation
干预措施: fan-shaped photocoagulation (Procedure)
结局指标
主要结局
Mean change from baseline in best-corrected visual acuity (BCVA)
时间窗: 3 years
Assessed using the ETDRS protocol
次要结局
- chang from baseline in structure of retina(3 years)
- chang from baseline in retinal neovascularization(3 years)
- Mean change from baseline in visual field(3 years)
研究者
Xiangtian Zhou
professor
Wenzhou Medical University
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