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临床试验/NCT02157025
NCT02157025招募中不适用

A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年2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
招募中
入组人数
20
试验地点
1
主要终点
Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)

研究概览

简要总结

The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities
  • •Able and willing to complete VF testing at 2 study visits about a week apart
  • •Provide informed consent

排除标准

  • •History of having previously completed a VF test using Humphrey static perimetry
  • •Inability to understand study or communicate responses (cognitive impairment)
  • •Unable to understand, read and speak English fluently

研究组 & 干预措施

Cartoon Intervention

Experimental

Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry

干预措施: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry (Device)

Usual Care

Active Comparator

Usual care procedures for Humphrey perimetry in young children

干预措施: Usual Care procedures during Humphrey perimetry for children (Other)

结局指标

主要结局

Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)

时间窗: 1 week

Within subject, the investigators will determine the coefficient of variation in the mean deviation scores obtained at the two sessions a week apart (dB). The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the test-retest variability.

次要结局

  • Humphrey Visual Field Reliability Indices and Ratings(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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