Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old (ATS16)

• Amblyopic eye visual acuity [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: No ]
  

• Sound eye visual acuity [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  
• Differences between treatment groups in stereoacuity [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  
• Ocular alignment [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  
• Treatment group comparison of the proportion of patients who have improved by 2 or more logMAR visual acuity lines [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: No ]
  
• Patients in both groups who have improved by 1 or more lines from baseline to the 10-week outcome exam will have a treatment group comparison of the proportion of patients with at least 2 logMAR lines of visual acuity improvement [ Time Frame: Last study visit ] [ Designated as safety issue: No ]
  
• Patients in both groups who have improved by 1 or more lines from baseline to the 10-week outcome exam will have a treatment group comparison of logMAR visual acuity scores in the amblyopic eye [ Time Frame: Last study visit ] [ Designated as safety issue: No ]
  

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.