ReSTOR Natural +3.0D (Diopter) Study In Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Uncorrected Intermediate Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Planned bilateral cataract removal by phacoemulsification
- •Potential postoperative best corrected visual acuity of 0.5 or over
- •1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry
排除标准
- •Poorly controlled glaucoma
- •Progressive diabetic retinopathy
结局指标
主要结局
Uncorrected Intermediate Visual Acuity
时间窗: 1 year after surgery
Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Distance Visual Acuity
时间窗: 1 year after surgery
Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Uncorrected Near Visual Acuity
时间窗: 1 year after surgery
Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
次要结局
未报告次要终点