NCT00731640已完成4 期
Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral operable cataract
- •Candidate for presbyopic intraocular lens (IOL)
排除标准
- •Ocular comorbidities compromising primary outcome
- •Bilateral cataracts
研究组 & 干预措施
Monofocal
Active Comparator
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
干预措施: ReSTOR (Device)
Phakic
Active Comparator
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
干预措施: ReSTOR (Device)
结局指标
主要结局
Visual Acuity
时间窗: 6 months
Uncorrected 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
- Contrast Sensitivity(6 Months)
- Patient Satisfaction(6 Months Postoperative)
- Spectacle Independence(6 Months)
研究者
研究点 (1)
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