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一种更具吸引力的视野测试,可提高儿科的使用率和可靠性

2026年9月25日 更新者:Nova Southeastern University

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.

研究概览

研究类型

介入性

注册 (实际的)

11

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Fort Lauderdale、Florida、美国、33328
        • The Eye Care Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 8年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ages 5-8
  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cartoon Intervention

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

有源比较器:Usual Care

Usual care procedures for Humphrey perimetry in young children

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)
大体时间: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.

1 week

次要结果测量

结果测量
措施说明
大体时间
Humphrey Visual Field Reliability Indices and Ratings
大体时间:1 week

The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the visual field reliability criteria (false negatives, false positives and fixation losses; expressed as %), and operator ratings (subjects' fixation, cooperation and fatigue; scale 1 to 5).

1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Ava Bittner、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年2月1日

初级完成 (实际的)

2026年2月1日

研究完成 (实际的)

2026年7月1日

研究注册日期

首次提交

2014年6月2日

首先提交符合 QC 标准的

2014年6月3日

首次发布 (估计的)

2014年6月5日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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