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

Glaucoma, Suspect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02157025
• Other study ID #: KID_VF
• Status: Recruiting
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Nova Southeastern University
• Contact: Katherine E Green, OD
• Phone: 954-262-4227
• Email: kgreen2[@]nova.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Usual Care procedures during Humphrey perimetry for children

Locations

Country	Name	City	State
United States	The Eye Care Institute	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	1 week