Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

• Sound eye visual acuity [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: Yes ]
• Differences between treatment groups in stereoacuity [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: Yes ]
• Ocular alignment [ Time Frame: 10 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 ]

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.

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.

• Device: Eye Patch
  42 hours patching per week (averaging 6 hours patching daily)
  Other Names:

  • Coverlet
  • 3M Opticlude
  • Ortopad
• Device: Eye Patch
  2 hours patching daily
  Other Names:

  • Coverlet
  • 3M Opticlude
  • Ortopad

• Active Comparator: Control
  2 hours daily patching
  Intervention: Device: Eye Patch
• Active Comparator: Intensified treatment
  42 hours per week of patching (averaging 6 hours daily)
  Intervention: Device: Eye Patch

Inclusion Criteria:

Major Eligibility Criteria for Run-in Phase

• Age 3 to < 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines

• Amblyopia treatment within the past 6 months subject to the following stipulations:

  • No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
  • No simultaneous treatment with patching and atropine
  • No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D

  • Maximum level of treatment within the past 6 months:

    • Patching: up to 2 hours daily
    • Atropine: up to once daily
• Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.

Eligibility Criteria for Randomization:

• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
• Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.

Exclusion Criteria:

• Currently using vision therapy or orthoptics
• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
• Prior intraocular or refractive surgery
• Known skin reaction to patch or bandage adhesives