Glaucoma, SuspectNCT02157025
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
A study testing Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry in people with Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, run by Nova Southeastern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Suspect, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, Congenital Coloboma of the Optic Nerve
- What is being tested?
- Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Eye Care Institute
Fort Lauderdale, Florida, 33328
About this study
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
- Being tested
- Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry, Usual Care procedures during Humphrey perimetry for children
- Keywords
- Humphrey visual fields, perimetry, pediatrics
- Medical subject headings
- Ocular Hypertension, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, Coloboma of optic nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetryDevice
Usual Care procedures during Humphrey perimetry for childrenOther
| Study group | Role | What they receive |
|---|---|---|
| Cartoon Intervention | Experimental | Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry Receives: Device: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry |
| Usual Care | Active comparator | Usual care procedures for Humphrey perimetry in young children Receives: Other: Usual Care procedures during Humphrey perimetry for children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2026
- Study completionJul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, SuspectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ava Bittner, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157025
- Sponsor's protocol ID
- KID_VF
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2014
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
- ClinicalTrials.gov ID
- NCT02157025
- Acronym / sponsor ID
- KID_VF
- 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
- Keywords
- Humphrey visual fields, perimetry, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2026 (actual)
- Study completion
- Jul 2026 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cartoon Intervention | Experimental | Device: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetryCartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry |
| Usual Care | Active comparator | Other: Usual Care procedures during Humphrey perimetry for childrenUsual care procedures for Humphrey perimetry in young children |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry | Device | Cartoon Intervention |
| Usual Care procedures during Humphrey perimetry for children | Other | Usual Care |
Primary outcome
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 secondary outcome
Humphrey Visual Field Reliability Indices and Ratings
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ava Bittner study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry in people with Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.