- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157025
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
July 12, 2023 updated by: Nova Southeastern University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katherine E Green, OD
- Phone Number: 954-262-4227
- Email: kgreen2@nova.edu
Study Contact Backup
- Name: So Yeon (Sharon) Lee, OD
- Phone Number: 954-262-1478
- Email: slee@nova.edu
Study Locations
-
-
Florida
-
Fort Lauderdale, Florida, United States, 33328
- Recruiting
- The Eye Care Institute
-
Principal Investigator:
- Katherine Green, OD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)
Time Frame: 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.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Humphrey Visual Field Reliability Indices and Ratings
Time Frame: 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).
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimated)
June 5, 2014
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KID_VF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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