NCT02049567已完成不适用
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PowerVision
- 入组人数
- 170
- 试验地点
- 9
- 主要终点
- Best corrected distance visual acuity (BCDVA)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
详细描述
Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
- •Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
- •Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
- •Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
- •Taking systemic medications that may confound the outcome or increase the risk to the subject;
- •Ocular conditions that may predispose for future complications;
- •Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
- •Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
- •Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Best corrected distance visual acuity (BCDVA)
时间窗: Month 6
Visual acuity of the eye will be tested with the correction in place.
Accommodative amplitude
时间窗: Month 6
Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.
Rates of adverse events
时间窗: Up to Month 36
Adverse events will be collected from time of enrollment to study exit
次要结局
未报告次要终点
研究者
研究点 (9)
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