NCT00818116已完成4 期
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Uncorrected and Best Corrected Visual Acuities (Near and Distance)
研究概览
简要总结
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
- •50~75 years of age
- •<1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
排除标准
- •Patients with pre-existing conditions that could skew the results.
- •Any of conditions before and during surgery specified in the product information.
结局指标
主要结局
Uncorrected and Best Corrected Visual Acuities (Near and Distance)
时间窗: 6 Months Following Cataract Surgery
Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
次要结局
未报告次要终点
研究者
研究点 (2)
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