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Recruiting NCT02157025

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

No phase Interventional Glaucoma, Suspect Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System Congenital Coloboma of the Optic Nerve Optic Nerve Head Pits, Bilateral Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry, Usual Care procedures during Humphrey perimetry for children.
Who it may be relevant to
Registry conditions: Glaucoma, Suspect, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, Congenital Coloboma of the Optic Nerve, Optic Nerve Head Pits, Bilateral Congenital. Basic parameters: 5 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
  • Other Usual Care procedures during Humphrey perimetry for children

Primary outcome measures

  • Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB) [Time frame: 1 week]
Secondary outcome measures (1)
  • Humphrey Visual Field Reliability Indices and Ratings [Time frame: 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The Eye Care Institute — Fort Lauderdale

Identifiers

NCT: NCT02157025 · KID_VF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗