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临床试验/NCT02258113
NCT02258113Unknown不适用

Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep

Ocuspecto Oy2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
Visual acuity

研究概览

简要总结

The aim of this study is to measure visual acuity, contrast sensitivity and visual field by SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is based on reaction times in visual decision- making task, where the subject is allowed to move eyes and where the fixation is verified by the subject himself in contrast to standard automatic perimetry (SAP) where prolonged stationary fixation and external fixation monitoring apparatus is required. Reaction-time based visual field device Ocusweep is compared to generally used SAP methods. Those tests will be done for healthy volunteers and for persons with diagnosed eye or brain disease.

Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also done under cognitive load and with instructions to cheat the test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers
  • Persons suffering diagnosed eye disease
  • Persons suffering diagnosed brain disease

排除标准

  • No diabetes
  • Only one diagnosed disease

结局指标

主要结局

Visual acuity

时间窗: One visit per one patient (1h/visit)

Visual acuity is measured as logMAR unit at the one visit for each patient using a novel reaction-time based visual field device and comparable method.

次要结局

  • Contrast sensitivity(One visit per one patient (1h/visit))
  • Reaction time visual field(One visit per one patient (1h/visit))
  • Vision based choice reaction time(One visit per one test subject (1h/visit))

研究者

发起方
Ocuspecto Oy
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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