NCT00963742已完成不适用
Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
Lenstec Incorporated0 个研究点目标入组 390 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 主要终点
- Distance Best Corrected Visual Acuity
研究概览
简要总结
The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.
详细描述
The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Cataract requiring cataract extraction
- •Study IOL to only be implanted in 1 eye
- •Distance BCVA 20/40 or worse or glare acuity worse than 20/30
- •Ability to comply with study follow-up requirements
排除标准
- •Patients with serious corneal disease, previous surgery or serious systemic disease
- •Ocular condition that could impact vision after cataract surgery
- •Pregnant or lactating women
- •Use of ocular or systemic medications that could impact vision
结局指标
主要结局
Distance Best Corrected Visual Acuity
时间窗: 1 year
次要结局
- FDA IOL Grid Adverse Events(through 1 year)
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