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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: 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.

Detailed Summary:
Sponsor: Nova Southeastern University

Current Primary Outcome: Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB) [ Time Frame: 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.


Original Primary Outcome: Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB) [ Time Frame: 1 week ]

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


Current Secondary Outcome: Humphrey Visual Field Reliability Indices and Ratings [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: Nova Southeastern University

Dates:
Date Received: June 2, 2014
Date Started: February 2015
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017