Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Tear film break-up time
研究概览
简要总结
The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must have clinically diagnosed Dry Eye or Sjörgren's syndrome.
- •Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
- •Ability to give informed consent
- •Willing to spend time for the study; approximately 30 minutes for a visit
- •Either gender
- •Any racial or ethnic origin
排除标准
- •Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
- •Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy.
- •Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago.
研究组 & 干预措施
Dry Eye Disease or Sjogren's Disease
Capturing images of the tear surface using the multi-colored Placido disk
干预措施: Multi-colored Placido disk imaging (Procedure)
Control
Capturing images of the tear surface using the multi-colored Placido disk
干预措施: Multi-colored Placido disk imaging (Procedure)
结局指标
主要结局
Tear film break-up time
时间窗: up to 3 seconds
The multi-colored Placido disk will collect images of the tear film with the aim to have usable data for more extended periods of time. This instrument measures tear film break-up time in seconds using a video recording of the tear surface.
次要结局
未报告次要终点
研究者
Geunyoung Yoon
Principle Investigator
University of Rochester
