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

NCT ID: NCT02157025

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2027-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cartoon Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Usual Care

Usual care procedures for Humphrey perimetry in young children

Group Type: ACTIVE_COMPARATOR

Usual Care procedures during Humphrey perimetry for children

Intervention Type: OTHER

Interventions

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

Intervention Type: DEVICE

Usual Care procedures during Humphrey perimetry for children

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ava Bittner

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

The Eye Care Institute

Fort Lauderdale, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

So Yeon Lee, OD

Role: CONTACT

slee@nova.edu

954-262-1478

Ava Bittner, OD, PhD

Role: CONTACT

abittne1@jhmi.edu

Other Identifiers

KID_VF

Identifier Type: -

Identifier Source: org_study_id