NCT01261975已完成4 期
Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Refractive Stability
研究概览
简要总结
The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
- •Subject's ocular media must be clear except for the presence of the cataract in both eyes.
排除标准
- •Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
结局指标
主要结局
Refractive Stability
时间窗: 12 weeks
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
次要结局
- Surgically Induced Astigmatism (SIA)(Visits 4-8)
- Best Corrected Visual Acuity(visit 5, visit 6, visit 7, visit 8)
- Uncorrected Visual Acuity(visit 5, visit 6, visit 7, visit 8)
研究者
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