NCT04139746已完成不适用
Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Anatomical reattachment of the retina
研究概览
简要总结
To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provision of written informed consent;
- •phakic patients aged < 60 years with no or minimal media opacity;
- •single or multiple retinal breaks (within 1 clock hour) between 8 to 4 o'clock hours;
- •patients' capability to maintain suggested head positioning for 5 days after the procedure.
排除标准
- •retinal detachment with poor subretinal fluid (absence of severe SBRD);
- •holes, lattice degeneration or traction within the inferior 4 clock hours;
- •posterior retinal break, situated behind the equator, not suitable for cryotherapy;
- •any sign of PVR or severe glaucoma;
- •myopia above 10 diopters.
结局指标
主要结局
Anatomical reattachment of the retina
时间窗: 12-month
次要结局
- Refractive error change(12-month)
研究者
Francesco Semeraro
Prof. Francesco Semeraro
Università degli Studi di Brescia
研究点 (2)
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