NCT01166971已完成4 期
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Defocus Curve
研究概览
简要总结
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with bilateral cataracts
- •candidate for presbyopic lens
排除标准
- •>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
- •pre-existing conditions that could skew the results
研究组 & 干预措施
ReSTOR +3
Experimental
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
干预措施: ReSTOR +3 (Device)
Tecnis MF
Active Comparator
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
干预措施: Tecnis MF (Device)
结局指标
主要结局
Defocus Curve
时间窗: 3 months after surgery
A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".
次要结局
未报告次要终点
研究者
研究点 (3)
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