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

Sponsor

Nova Southeastern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02157025

Collaborator

(none)

Enrollment

Location

Arms

106

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Suspect Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System Congenital Coloboma of the Optic Nerve Optic Nerve Head Pits, Bilateral Congenital	Device: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry Other: Usual Care procedures during Humphrey perimetry for children	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Humphrey Visual Field Reliability Indices and Ratings [1 week]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

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:

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