Recruiting

Visual Field Test

Sponsor:

Nova Southeastern University

Code:

NCT02157025

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

Eligibility Criteria

Sex: All

Age: 5 - 8

Healthy Volunteers: Accepted

Interventions

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

Usual Care procedures during Humphrey perimetry for children

Study Details

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

Study ID

NCT02157025

Start date

Feb, 2015

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 8

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cartoon Intervention

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

Interventions

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

Usual Care procedures during Humphrey perimetry for children

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ava Bittner, OD, PhD

abittne1@jhmi.edu

Locations

The Eye Care Institute

Recruiting

Fort Lauderdale, Florida, United States, 33328

Principal Investigator:

So Yeon Lee, OD

More Information

Sponsor

Nova Southeastern University

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • Humphrey visual fields
  • perimetry
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2025-09-10.