NCT02081170Unknown不适用
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- macular hole closure
研究概览
简要总结
The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Macular hole with any of following condition
- •High myopia (spherical equivalent ≤ -6.0 Diopters)
- •Large size macular hole (Diameter > 600 microns)
- •Recurred or failed macular hole from previous surgery
- •Chronic macular hole (symptom duration > 6 months)
排除标准
- •Systemic infection
- •Hematologic disease
- •Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration
结局指标
主要结局
macular hole closure
时间窗: 6 months
次要结局
- best-corrected visual acuity(6 months)
- metamorphopsia score(6 months)
- safety outcome(6 months)
研究者
研究点 (2)
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