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NCT02157025 · ClinicalTrials.gov registry record · NA
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
A NA study of Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, sponsored by Nova Southeastern University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02157025: Recruiting NA study of Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, sponsored by Nova Southeastern University.
NCT02157025 is a NA study of Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System that is actively recruiting participants, run by Nova Southeastern University. The registered enrollment target is 20 participants, below the 113-participant average among 3 other Glaucoma, Suspect trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02157025, a NA study of Glaucoma, Suspect and Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System, is actively recruiting participants, sponsored by Nova Southeastern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
- OTHER Usual Care procedures during Humphrey perimetry for children
Study Locations (1)
Florida
- The Eye Care Institute - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-02 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT02157025 shows while recruiting
NCT02157025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 113-participant average among 3 other Glaucoma, Suspect trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Glaucoma, Suspect appearing as the primary indexed condition, and to 2 interventions - of which Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry is the first listed.
NCT02157025 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02157025 about?
NCT02157025 is a clinical study titled "A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics". 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...
What is the current status of trial NCT02157025?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2015-02. Estimated completion is 2027-12.
What conditions does trial NCT02157025 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT02157025?
The interventions under investigation include: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry (DEVICE), Usual Care procedures during Humphrey perimetry for children (OTHER).
Who is sponsoring clinical trial NCT02157025?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02157025 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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