AcrySof IQ Toric A-Code Post-Market Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
研究概览
简要总结
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
详细描述
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cataracts with planned cataract removal by phacoemulsification
- •Calculated lens power within the available range
- •Able to sign informed consent and complete all study visits
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye conditions as specified in the protocol
- •Uncontrolled glaucoma
- •Pregnancy, current or planned
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Acrysof IQ Toric A-code IOL
IOL implanted during cataract surgery
干预措施: AcrySof IQ Toric A-code IOL (Device)
Acrysof IQ Toric A-code IOL
IOL implanted during cataract surgery
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
时间窗: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
次要结局
未报告次要终点