NCT03531853已完成不适用
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Duke University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年11月14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
- 14
- 试验地点
- 2
- 主要终点
- Concordance
研究概览
简要总结
The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system
- •Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe
- •Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center
排除标准
- •Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study
- •Pilot (ER): hemodynamically unstable, unable to consent
- •Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality
结局指标
主要结局
Concordance
时间窗: Up to 18 months
By the ability to detect cells in the eye compared to clinical exam
次要结局
未报告次要终点
研究者
研究点 (2)
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