NCT02888210已完成3 期
Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Corrected visual acuity
研究概览
简要总结
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
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
- •Patients who intend to undergo phacoemulsification cataract extraction
排除标准
- •Patients who undergo secondary implantation
- •Patients with vision loss induced by causes other than cataract
- •Patients who the principal investigator/subinvestigator considers ineligible for enrollment
研究组 & 干预措施
MD-15
Experimental
Investigational intraocular lens
干预措施: MD-15 Intraocular Lens (Device)
结局指标
主要结局
Corrected visual acuity
时间窗: Week 52
次要结局
未报告次要终点
研究者
研究点 (1)
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