Binocularly Balanced Viewing Study
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      Amblyopia is treated by glasses and patches or blurring eyedrops to the good eye. This works
      in about 70% of children, but parents and children strongly dislike these treatments which
      may carry on for years and involve frequent clinic visits. In this pilot trial, 66 children
      will receive, at random, either a Nintendo 3DSXL console with movies, or standard
      patching/blurring eye-drop treatment. The Investigators will monitor adverse events (double
      vision), change in the balance between the two eyes and in visual acuity over 16 weeks.
    

Detailed description: 
      "Lazy eye" (amblyopia) is the commonest sight problem in children, affecting about one in 30
      children. It is caused by a difference in spectacle prescription between the eyes and/or a
      squint (eye misalignment), with the brain ignoring one eye. Amblyopia is treated by glasses
      and patches or blurring eyedrops to the good eye. This works in about 70% of children, but
      parents and children strongly dislike these treatments which may carry on for years and
      involve frequent clinic visits.

      The Investigators have developed an exciting new treatment: children watch customized movies
      for an hour a day on a hand-held 3D computer-game console. The Investigators blur the picture
      that the good eye sees to match it with what the weaker eye sees. They have tested this
      approach on 22 children, with an average improvement in vision by three lines on the test
      chart over 8 - 24 weeks, which may be faster than with standard treatment. Parents and
      children the Investigators have spoken with like both the idea of research in this area and
      the engaging nature of this device. The Investigators now need to assess how the new
      treatment compares with standard treatment, but first need to ensure that the new treatment
      is safe and that families will use it.

      In this pilot trial, 66 children will receive, at random, either a Nintendo 3DSXL console
      with movies, or standard patching/blurring eye-drop treatment. The Investigators will monitor
      adverse events (double vision), change in the balance between the two eyes and in visual
      acuity over 16 weeks. Parents and children have helped develop this pilot - this involvement
      will be continued throughout the study. At study completion, children and parents will be
      involved in deciding how best to communicate the findings on hospital websites, in
      newsletters, at conferences and in medical journals.
    

Intervention name(s): Balanced Binocular Viewing (BBV); Standard Therapy - Occlusion (patching) or blurring (atropine)
Intervention type(s): Device; Other
Intervention description(s): The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).; The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-group parallel randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment