NCT01933750已完成不适用
A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
Refocus Ocular Europe, B.V.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年2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
- 20
- 试验地点
- 1
- 主要终点
- Near Visual Acuity
研究概览
简要总结
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses
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
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45 or older at commencement of study
- •Best Corrected Distance Visual Acuity of .80 (20/25) or better
- •Patients must be alert, mentally competent, and able to comply with clinical study requirements
排除标准
- •Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery
- •Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- •Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
结局指标
主要结局
Near Visual Acuity
时间窗: 12 Months
Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months
次要结局
- Presence of Significant Safety Events(24 months)
- Uncorrected Near Visual Acuity(12 Months)
研究者
研究点 (1)
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