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

Primary Purpose

Glaucoma, Suspect, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, Congenital Coloboma of the Optic Nerve

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
Usual Care procedures during Humphrey perimetry for children
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma, Suspect focused on measuring Humphrey visual fields, perimetry, pediatrics

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Eye Care InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cartoon Intervention

Usual Care

Arm Description

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

Usual care procedures for Humphrey perimetry in young children

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 2, 2014
Last Updated
July 12, 2023
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT02157025
Brief Title
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
Official Title
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cartoon Intervention
Arm Type
Experimental
Arm Description
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care procedures for Humphrey perimetry in young children
Intervention Type
Device
Intervention Name(s)
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
Intervention Type
Other
Intervention Name(s)
Usual Care procedures during Humphrey perimetry for children
Primary Outcome Measure Information:
Title
Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Humphrey Visual Field Reliability Indices and Ratings
Description
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).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine E Green, OD
Phone
954-262-4227
Email
kgreen2@nova.edu
First Name & Middle Initial & Last Name or Official Title & Degree
So Yeon (Sharon) Lee, OD
Phone
954-262-1478
Email
slee@nova.edu
Facility Information:
Facility Name
The Eye Care Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Green, OD

12. IPD Sharing Statement

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

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