Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the effectiveness of increasing prescribed patching
      treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment
      and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to
      20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching
      until no improvement, followed by randomization of eligible patients to patching 2 hours
      daily versus an average of 6 hours daily (42 hours per week). The primary objective is to
      determine if increasing patching dosage will improve visual acuity in patients with amblyopia
      still present after visual acuity has stabilized with initial treatment.
    

Detailed description: 
      Amblyopia is the most common cause of monocular visual impairment in both children and young
      and middle-aged adults. Both patching and atropine are accepted treatment modalities for the
      management of moderate amblyopia in children.1 Many practitioners prescribe 2 hours daily
      patching as initial therapy for amblyopia. However, many children fail to achieve normal
      visual acuity in the amblyopic eye with this regimen. In a randomized trial conducted by
      PEDIG comparing patching regimens, 71 of 92 patients with moderate amblyopia (77%) had
      amblyopic eye visual acuity of 20/32 or worse after 4 months of patching 2 hours daily.2 In
      another PEDIG randomized trial comparing patching to spectacles alone after a period of
      refractive adaptation, patients were treated with 2 hours daily patching and followed every 5
      weeks until there was no improvement in amblyopic eye acuity. Fifty-five of 70 patients with
      moderate amblyopia (79%) and 14 of 14 patients with severe amblyopia (100%) had best-measured
      amblyopic eye visual acuity of 20/32 or worse after a median treatment period of 10 weeks.3
      When improvement with initial therapy stops and amblyopia is still present, treatment options
      include increasing the dosage of current treatment, switching to another treatment,
      maintaining the same treatment and dosage for additional months, or combining treatments.
      Many clinicians will choose to increase the dosage of the current treatment, in part because
      families have become comfortable with that particular mode of treatment. However, it is
      unknown whether increasing occlusion dosage will improve amblyopic eye visual acuity in these
      patients. We are unaware of any reports of response to intensified treatment of amblyopia.
    

Intervention name(s): Eye Patch; Eye Patch
Intervention type(s): Device; Device
Intervention description(s): 42 hours patching per week (averaging 6 hours patching daily); 2 hours patching daily
Other intervention name(s): Coverlet; 3M Opticlude; Ortopad; Coverlet; 3M Opticlude; Ortopad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia; patching; occlusion