NCT00759096已完成不适用
Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Near Uncorrected Visual Acuity(UCVA
研究概览
简要总结
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥21 years of either gender or any race
- •Potential post-op VA 20/20
- •Pre-op astigmatism ≤ 1.0D
- •Able to sign the informed consent
- •Able to complete all required postoperative visits
- •Planned cataract removal by phaco
- •Clear intraocular media other than cataract
排除标准
- •Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
- •Any corneal pathology and previous corneal refractive surgery
- •Patients with unrealistic expectations in anticipated post-op VA
- •Happy to wear glasses
- •Occupational night driver
结局指标
主要结局
Near Uncorrected Visual Acuity(UCVA
时间窗: 6 months after surgery of 2nd eye
Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
次要结局
- Contrast Sensitivity(6 months after sugery of the 2nd eye)
研究者
研究点 (2)
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