NCT00804726终止不适用
A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subjects must have a clinically documented diagnosis of age-related cataract.
- •Subjects must have clear intraocular media other than cataract.
- •Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
排除标准
- •Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- •Subjects with diagnosis of degenerative visual disorder.
- •Subjects who have any inflammation or edema (swelling) of the cornea.
- •Subjects with immunodeficiency disorders.
- •Subjects who have had previous intraocular surgery in the study eye.
- •Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
- •Subjects with chronic use of systemic steroids or immunosuppressive medications.
研究组 & 干预措施
Akreos MI Five-O
Experimental
Accommodating intraocular lens
干预措施: Akreos MI Five-O (Device)
结局指标
主要结局
Visual acuity
时间窗: 5 visits up to 420 days
Uncorrected distance visual acuity Best corrected distance visual acuity Uncorrected near visual acuity Uncorrected intermediate visual acuity Near visual acuity with distance best correction
次要结局
- Visual acuity(5 visits up to 420 days)
研究者
研究点 (2)
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