NCT02649738进行中（未招募）不适用
Use of Preserved Corneal Tissue Inlay to Treat Keratoconus
Cornea and Laser Eye Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Corneal tissue inlay for keratoconus
研究概览
简要总结
This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.
详细描述
The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age, male or female, of any race
- •Provide written informed consent and sign a HIPAA form
- •Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- •For females: Must not be pregnant
- •Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus.
排除标准
- •Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- •If female, pregnant
- •Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
- •Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications For example: a history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
- •A history of delayed corneal healing in the eye to be treated
- •Have used an investigational drug or device within 30 days of the study
结局指标
主要结局
Corneal tissue inlay for keratoconus
时间窗: 6 months
Change in maximum keratometry on corneal topography
次要结局
未报告次要终点
研究者
研究点 (2)
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