NCT01547429暂停不适用
Artisan Aphakia Lens for the Correction of Aphakia in Adults
Ophtec USA35 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
- 35
- 主要终点
- Improvement in best corrected visual acuity
研究概览
简要总结
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
详细描述
Not desired
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
- •Patient must agree to comply with the visit schedule and other requirements of the study
排除标准
- •Patients that are not able to meet the extensive postoperative evaluation requirements
- •Mentally retarded patients
- •When the patient has no useful vision or vision potential in the fellow eye
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
- •Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
- •Patients with uncontrolled glaucoma
- •High preoperative intraocular pressure, >25 mmHg
- •Chronic or recurrent uveitis or history of the same
- •Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
- •Patients with a retinal detachment or a family history of retinal detachment
- •Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
- •Diabetes mellitus
- •Pregnant, lactating, or plans to become pregnant during the course of this study
结局指标
主要结局
Improvement in best corrected visual acuity
时间窗: 3 year follow up
次要结局
未报告次要终点
研究者
研究点 (35)
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