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临床试验/NCT02148497
NCT02148497已完成不适用

Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data

University of Rochester1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

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

Other

Capturing images of the tear surface using the multi-colored Placido disk

干预措施: Multi-colored Placido disk imaging (Procedure)

Control

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geunyoung Yoon

Principle Investigator

University of Rochester

研究点 (1)

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