Augmenting Atropine Treatment 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 adding a plano lens to weekend
      atropine after visual acuity has stabilized with weekend atropine but 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 weekend atropine until no improvement, followed
      by randomization of eligible patients to weekend atropine treatment with a plano lens over
      the sound eye versus without a plano lens over the sound eye. The primary objective is to
      determine if adding a plano lens to weekend atropine 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 weekend atropine
      as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity
      in the amblyopic eye after treatment with this regimen. In a randomized trial conducted by
      PEDIG comparing atropine regimens, 58 of 83 patients with moderate amblyopia (70%) had
      amblyopic eye visual acuity of 20/32 or worse after 4 months of treatment with weekend
      atropine.2 In another PEDIG randomized trial comparing atropine with a plano lens versus
      without a plano lens for initial treatment of amblyopia, 60 of 84 patients with moderate
      amblyopia (71%) had amblyopic eye visual acuity of 20/32 or worse after 16 weeks of treatment
      with weekend atropine.3 When improvement stops after initial therapy and amblyopia is still
      present, treatment options include increasing the dosage of current treatment, switching to
      another treatment, maintaining the same treatment and dosage, or combining treatments. Many
      clinicians will add a plano lens over the sound eye to atropine treatment, in part because
      families using atropine have become comfortable with its use. This option is limited to
      children with hypermetropia in the sound eye. However, it is unknown whether adding a plano
      lens over the sound eye will improve amblyopic eye visual acuity more than continuing
      atropine alone in patients who have shown no improvement after initial treatment with
      atropine. In a PEDIG randomized trial comparing patching to atropine for initial treatment of
      amblyopia, a plano lens was prescribed for the sound eye for 55 patients who had not improved
      to 20/30 or at least 3 lines after 4 months of daily atropine use.1, 4 Their mean acuity
      improvement prior to using the plano lens was 1.0 line, compared with 1.6 lines after
      prescribing the plano lens. We are unaware of any reports of the response of treatment of
      amblyopia still present after initial treatment with weekend atropine.
    

Intervention name(s): Atropine; Plano lens; Atropine
Intervention type(s): Drug; Device; Drug
Intervention description(s): Weekend atropine 1%; plano lens over the sound eye; Weekend atropine 1%
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amblyopia; atropine; Plano lens