Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
研究概览
简要总结
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with cataracts
排除标准
- •Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings
研究组 & 干预措施
ReSTOR Aspheric +4
ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
干预措施: ReSTOR (Device)
Tecnis MF
Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
干预措施: Tecnis (Device)
Acri.LISA
Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
干预措施: Acri.LISA (Device)
结局指标
主要结局
Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
时间窗: 6 months
Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.
次要结局
- Contrast Sensitivity(6 months)
- Defocus Curve(6 months post-operative)
