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

Launched by JAEB CENTER FOR HEALTH RESEARCH · Jul 21, 2009

Keywords

ClinConnect Summary

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 mo...

Gender

ALL

Eligibility criteria

• 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