NCT00370760Unknown3 期
Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 试验地点
- 1
- 主要终点
- Retinal reattachment rate
研究概览
简要总结
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cases with rhegmatogenous retinal detachment complicated by PVR grade C
排除标准
- •History of pars plana vitrectomy for PVR grade C
- •History of silicone oil injection
- •History of ocular trauma
- •Diabetic retinopathy
- •Giant retinal tear
研究组 & 干预措施
1
Active Comparator
干预措施: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Retinal reattachment rate
次要结局
- reoperation,
- ocular hypotony,
- visual acuity
- macular pucker,
- PVR recurrence,
研究者
研究点 (1)
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