NCT02838004已完成不适用
An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- UDVA (Uncorrected Distance Visual Acuity)
研究概览
简要总结
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
详细描述
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender and age above 18 years.
- •Refractive lens exchange (RLE) or cataract surgery.
- •Healthy corneas, not treated surgically.
- •Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
- •Patients request to receive the IOL MINI WELL READY implant
排除标准
- •Previous corneal surgery (i.e. pterygium, refractive surgery).
- •Eye diseases determining a probable postoperative visual acuity < 20/
- •Pseudoexfoliation.
- •Abnormal pupil size and position.
- •Use of contact lens 30 days before the preoperative visit.
- •Corneal warpage.
- •Predicted postoperative corneal astigmatism higher than 1 D.
结局指标
主要结局
UDVA (Uncorrected Distance Visual Acuity)
时间窗: 30 days
Visual acuity mesurement
次要结局
- Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).(4 months)
研究者
研究点 (1)
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