NCT00825513已完成4 期
Monocular Study to Evaluate the Safety and Effectiveness of the Akreos™ Toric IOL When Used to Correct Primary Aphakia With the Reduction of Astigmatism
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
- •Subjects must require a lens power from 15 to 30 diopters.
排除标准
- •Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- •Subjects with corneal pathology potentially affecting topography.
研究组 & 干预措施
Akreos Advanced
Active Comparator
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)
干预措施: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO) (Device)
Akreos Toric
Experimental
Akreos Toric Intraocular Lens
干预措施: Akreos Toric IOL (Device)
结局指标
主要结局
Reduction of cylinder, Lens axis misalignment as determined by a photographic method.
时间窗: 32 months
次要结局
- Lens misalignment as determined by postoperative manifest refraction and vector analysis.(32 months)
研究者
研究点 (2)
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