NCT00758940撤回4 期
A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Near,intermediate,distance visual acuity
研究概览
简要总结
An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int
排除标准
- •Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers
研究组 & 干预措施
1
Experimental
Acrysof ReSTOR multifocal IOL
干预措施: Acrysof ReSTOR multifocal IOL (Device)
结局指标
主要结局
Near,intermediate,distance visual acuity
时间窗: pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery
次要结局
- contrast sensitivity(6 month after 2nd eye surgery)
研究者
研究点 (1)
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