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Trial record 3 of 6 for:    "coloboma"

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

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ClinicalTrials.gov Identifier: NCT02157025
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nova Southeastern University

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Suspect Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System Congenital Coloboma of the Optic Nerve Optic Nerve Head Pits, Bilateral Congenital Device: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry Other: Usual Care procedures during Humphrey perimetry for children Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cartoon Intervention
Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry
Device: 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
Other: Usual Care procedures during Humphrey perimetry for children



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157025


Contacts
Contact: Ava K Bittner, OD, PhD 954-262-1470 abittner@nova.edu
Contact: Erin Jenewein, OD, MS 954-390-7654 Jenewein@nova.edu

Locations
United States, Florida
Kids in Distress Clinic of The Eye Care Institute Recruiting
Fort Lauderdale, Florida, United States, 33305
Principal Investigator: Erin Jenewein, OD, MS         
Sponsors and Collaborators
Nova Southeastern University

Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02157025     History of Changes
Other Study ID Numbers: KID_VF
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Nova Southeastern University:
Humphrey visual fields
perimetry
pediatrics

Additional relevant MeSH terms:
Coloboma
Ocular Hypertension
Optic Nerve Diseases
Eye Abnormalities
Eye Diseases
Congenital Abnormalities
Cranial Nerve Diseases
Nervous System Diseases