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

NCT02157025 | Recruiting

• 1 other identifier: KID_VF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Humphrey visual fields; perimetry; pediatrics

Outcome Measures

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.

  1 week

Secondary Outcomes (1)

• Humphrey Visual Field Reliability Indices and Ratings

  1 week

Study Arms (2)

Cartoon Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Usual care procedures for Humphrey perimetry in young children

Other: Usual Care procedures during Humphrey perimetry for children

Interventions

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

Cartoon Intervention

Usual Care procedures during Humphrey perimetry for children OTHER

Usual Care

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

The Eye Care Institute

Fort Lauderdale, Florida, 33328, United States

RECRUITING

MeSH Terms

Conditions

Ocular Hypertension; Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System; Coloboma of optic nerve

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ava Bittner

  University of California, Los Angeles

  STUDY DIRECTOR

Central Study Contacts

So Yeon Lee, OD

CONTACT

954-262-1478; slee@nova.edu

Ava Bittner, OD, PhD

CONTACT

abittne1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: February 1, 2015
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)