NCT00842959已完成4 期
Check of Optical Features and Accuracy of the Zeiss ZO Lens of the Company Carl Zeiss Meditec After Selection and Calculation With OKULIX
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference between calculated and measured contrast vision.
研究概览
简要总结
It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine.
In the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Indication for cataract operation
- •Written informed consent of patient after information
排除标准
- •Immobility
- •Limited capacity of understanding
- •Diseases that hamper a follow-up examination
- •Astigmatism >2.0 D
- •Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens
- •Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis
结局指标
主要结局
Difference between calculated and measured contrast vision.
时间窗: postop.
Accuracy of prediction of target refraction
时间窗: postop.
次要结局
未报告次要终点
研究者
研究点 (2)
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