NCT00604305撤回不适用
A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- distance and near visual acuity
研究概览
简要总结
a comparison of two intraocular lenses in regard of accommodative power.
详细描述
A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 65
- •Required cataract operation in one or both eyes
- •BCVA potetial at least 20/30
- •Clear intraoccular media
- •Willing to participate in study as evidenced by signing a written Informed Consent
排除标准
- •Prior surgery at the selected eye
- •No light perception or poor potential for improvement
- •Phacodonesis and damaged zonules
- •Pupil size at least 6 mm.
- •History of uveitis
- •Macular disease decreasing vision below 20/30
- •Amblyopia
- •Axial length shorter than 21 mm and longer than 25 mm
研究组 & 干预措施
Acrysof
Active Comparator
Routine monofocal IOL
干预措施: Acrysof (Device)
Acuity's AIOL
Active Comparator
Accomodaing IOL
干预措施: Acuity's AIOL (Device)
结局指标
主要结局
distance and near visual acuity
时间窗: 1 year
次要结局
- centration pco(1 year)
研究者
Dr. Yaacov Rozenman
Head of eye department
Shaare Zedek Medical Center
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