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

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 11 participants (planned 20)
    • Primary completion date changed from estimate of Apr 2027 to Feb 2026
    • Study completion date changed from estimate of Dec 2027 to Jul 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Notable Primary completion date: Apr 2026 to Apr 2027
    • Study completion date: Dec 2026 to Dec 2027
    v13
  3. Notable Primary completion date: Apr 2024 to Apr 2026
    • Study completion date: Dec 2024 to Dec 2026
    • Site contact updated
    v12
  4. Notable Primary completion date: Apr 2023 to Apr 2024
    • Study completion date: Dec 2023 to Dec 2024
    • Study site revised
    v11
  5. Notable Primary completion date: Dec 2021 to Apr 2023
    • Study completion date: Dec 2021 to Dec 2023
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary and study completion dates: Dec 2020 to Dec 2021v9
  2. Notable Primary completion date: Dec 2018 to Dec 2020
    • Study completion date: Dec 2020
    v8
  3. Notable Primary completion date: Dec 2017 to Dec 2018v7
  4. Notable Primary completion date: Dec 2015 to Dec 2017v6
  5. Minor Re-verified, no change to tracked fieldsv5
  6. Minor Primary completion date: Jun 2015 to Dec 2015v4
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2014 to Feb 2015
    • Site details revised
    v3
  8. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02157025
Lead Sponsor Nova Southeastern University
Conditions
(from sponsor)
Glaucoma, Suspect, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, Congenital Coloboma of the Optic Nerve, Optic Nerve Head Pits, Bilateral Congenital
Related terms Coloboma of optic nerve, Ocular Hypertension, Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov