NCT01547442暂停不适用
Artisan Aphakia Lens for the Correction of Aphakia in Children
Ophtec USA38 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 300
- 试验地点
- 38
- 主要终点
- Best corrected distance visual acuity at 12 months postoperative
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
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
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 to 21 years of age
- •Have a visually significant cataract or need IOL replacement surgery
- •Compromised capsular bag prohibiting implantation of standard posterior IOL
- •Subject or parent/guardian must be able to comply with visit schedule and study requirements
- •Subject's legal representative must be able to sign the Informed Consent
排除标准
- •Under 2 years of age
- •Unable to meet Postoperative evaluation requirements
- •No useful vision or vision potential in fellow eye
- •Mentally retarded patients
- •History of corneal disease
- •Abnormality of the iris or ocular structure
- •ACD less than 3.2 mm
- •Uncontrolled glaucoma
- •IOP > 25 mmHg
- •Chronic or recurrent uveitis
- •Preexisting macular pathology that may complicate the ability to assess the benefit of this lens
- •Retinal detachment or family history
- •Retinal disease that may limit visual potential
- •Optic nerve disease that may limit visual potential
- •Diabetes mellitus
- •Pregnant, lactating or plan to become pregnant
结局指标
主要结局
Best corrected distance visual acuity at 12 months postoperative
时间窗: 5 years follow up
Determination of the ability of the lens to correct refractive error caused by aphakia
次要结局
未报告次要终点
研究者
研究点 (38)
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