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
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Accuracy of prediction of target refraction
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
研究组 & 干预措施
ZO
Other
XL Stabi ZO or Invent ZO
干预措施: Invent ZO (Device)
ZO
Other
XL Stabi ZO or Invent ZO
干预措施: XL Stabi ZO (Device)
结局指标
主要结局
Accuracy of prediction of target refraction
时间窗: postop.
Difference between calculated and measured contrast vision.
时间窗: postop.
次要结局
未报告次要终点
研究者
研究点 (1)
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