CClinicalTrials.gg
CompletedNCT02157025Updated Sep 30, 2026

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

An interventional study of Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry and Usual Care procedures during Humphrey perimetry for children in Glaucoma, Suspect, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System and Congenital Coloboma of the Optic Nerve, sponsored by Nova Southeastern University. Completed at 1 site in United States. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Nova Southeastern University · Not applicable, Interventional, and Diagnostic

Updated Sep 30, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma, Suspect
  • Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System
  • Congenital Coloboma of the Optic Nerve
  • Optic Nerve Head Pits, Bilateral Congenital

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Keywords

  • Humphrey visual fields
  • perimetry
  • pediatrics
03

In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's enrollment of 11 is below the median of 120 across 510 interventional studies indexed under Ocular Hypertension.

Browse Ocular Hypertension studies →

Lead sponsor

Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Cartoon Intervention

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

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

  • Active comparator
    Usual Care

    Usual care procedures for Humphrey perimetry in young children

    Other: Usual Care procedures during Humphrey perimetry for children

Interventions

  • DeviceCartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
  • OtherUsual Care procedures during Humphrey perimetry for children
06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1 week

Secondary outcomes

  1. Humphrey Visual Field Reliability Indices and Ratings

    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).

    Time frame: 1 week

07

Study locations

1 site
  • The Eye Care Institute
    Fort Lauderdale, Florida 33328, United States
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Sep 30, 2026
Primary completion
Apr 2027→Feb 2026 (actual)
Sep 30, 2026
Study completion
Dec 2027→Jul 2026 (actual)
Sep 30, 2026
Enrollment
20 (estimated)→11 (actual)
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Completed
    Primary completion Apr 2027→Feb 2026 (now actual)
    Study completion Dec 2027→Jul 2026 (now actual)
    Enrollment 20 (estimated)→11 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT02157025
Lead sponsor
Nova Southeastern University
Responsible party
Sponsor
First posted
Jun 5, 2014
Start date
Feb 2015
Primary completion
Feb 2026
Completion
Jul 2026
Last update
Sep 30, 2026

Study contacts

Ava Bittner
study director · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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