NCT02208232已完成不适用
Observation of Rotation of the MC 6125 AS Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IOL rotation
研究概览
简要总结
The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.
At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
排除标准
- •Preceding ocular surgery or trauma
- •Recurrent intraocular inflammation of unknown etiology
- •Uncontrolled glaucoma
- •Uncontrolled systemic or ocular disease
- •Blind fellow eye
- •Microphthalmus
- •Corneal abnormality
- •History of uveitis/iritis
- •Iris neovascularization
- •Pseudoexfoliation
- •Proliferative diabetic retinopathy
结局指标
主要结局
IOL rotation
时间窗: 6 months
The rotation of the IOLs over the first 6 postoperative months
次要结局
未报告次要终点
研究者
Rupert Menapace
Ao.Univ.-Prof. Dr.med.univ.
Medical University of Vienna
研究点 (1)
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