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NCT Number: NCT02157025

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

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.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Eye Care Institute

Fort Lauderdale, Florida, 33328, United States

Location status: Recruiting

Location contact

So Yeon Lee, OD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Usual Care procedures during Humphrey perimetry for children

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ava Bittner, OD, PhD

CONTACT

[email protected]

So Yeon Lee, OD

CONTACT

[email protected]

954-262-1478

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2014
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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