NCT02512432尚未招募不适用
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Corneal mapping to measure corneal thickness and steepening
研究概览
简要总结
To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.
详细描述
Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.
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
- •21 years of age, or older
- •have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
- •have clear central corneas
- •have a corneal thickness of 450 microns or greater at the proposed incision site
- •have corneal transplantation as the only remaining option to improve their visual function
排除标准
- •under 21 years of age
- •have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
- •do not have clear central corneas
- •do not have a corneal thickness of 450 microns or greater at the proposed incision site
- •do not have corneal transplantation as the only remaining option to improve their visual function
结局指标
主要结局
Corneal mapping to measure corneal thickness and steepening
时间窗: 1 year
Corneal Topography
次要结局
未报告次要终点
研究者
Christopher Heichel, MD
Associate Clinical Professor
University of California, San Diego
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