Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)
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 observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
研究组 & 干预措施
MC 6125 AS IOL + CTR
All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).
干预措施: cataract surgery (Procedure)
MC 6125 AS IOL + CTR
All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).
干预措施: intraocular lens (MC 6125 AS) (Device)
MC 6125 AS IOL + CTR
All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).
干预措施: capsular tension ring (CTR 13/11) (Device)
结局指标
主要结局
IOL rotation
时间窗: 6 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