NCT01615861已完成不适用
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases
- V4 (6M) endpoint: primary analysis
- V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have clear intraocular media other than cataract in the study eye.
- •Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.
排除标准
- •Subjects with ocular malformation in the study eye.
- •Subjects who have had previous surgery in the study eye.
- •Subjects with uncontrolled glaucoma in either eye.
- •Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
- •Subjects using medications known to potentially complicate cataract surgery.
结局指标
主要结局
Visual Acuity
时间窗: 6 months
Corrected distance visual acuity (CDVA)
次要结局
- Lens decentration(6 Months)
- Laser capsulotomy(24 Months)
- Incision size(6 Months)
- Refraction(6 Months)
- Visual Acuity(6 Months)
- EPCO(24 Months)
研究者
研究点 (2)
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