适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Percentage of eyes with subjective astigmatism 0.50D or less
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 22age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with bilateral cataract, aged 22 or more years at the time of consent
- •Patients who desire to receive bilateral cataract surgery and implantation
- •Patients with planned 2nd eye surgery within the period of 7-30 days after the 1st eye surgery
- •Other patients who meet the inclusion crirteria stipulated in the clinical trial protocol
排除标准
- •Patients with history of corneal transplant
- •Patients with history of refractive surgery
- •Patients with history of intraocular surgery
- •Patients with glaucoma
- •Patients with previous or acute retinal detachment
- •Patients with retinal degenerative disorders
- •Patients with a plan to have an intraocular surgery other than implantation of the investigational devices during the study period
- •Other patients who meet the exclusion crirteria stipulated in the clinical trial protocol
结局指标
主要结局
Percentage of eyes with subjective astigmatism 0.50D or less
时间窗: Month 4-6
Percentage of eyes with subjective astigmatism 0.50D or less in all eyes implanted with minimum cylinder power lens
Percentage of eyes with Uncorrected Near Visual Acuity 0.5 or more decimal
时间窗: Month 4-6
Percentage of eyes with Uncorrected Near Visual Acuity 0.5 or more decimal
次要结局
未报告次要终点
研究者
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