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Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee*. Randomized Trial to Evaluate Combined Patching and Atropine for Residual Amblyopia. Arch Ophthalmol. 2011;129(7):960–962. doi:10.1001/archophthalmol.2011.174
*Authors/Group Information: David K. Wallace, MD, MPH (lead author); Raymond T. Kraker, MSPH (lead author); Roy W. Beck, MD, PhD, Susan A. Cotter, OD, MS; Patricia L. Davis, MD; Jonathan M. Holmes, BM, BCh; Michael X. Repka, MD, MBA; Donny W. Suh, MD.
Many children fail to achieve normal visual acuity after treatment for amblyopia.1,2 This remaining deficit may be called residual amblyopia. We conducted a randomized trial to determine whether an intensive final push with combined patching and atropine sulfate can improve visual acuity in children with residual amblyopia.
A parent or guardian of each study subject gave written informed consent. The protocol is available at http://www.pedig.net. Eligible subjects were aged 3 to younger than 10 years and had strabismic and/or anisometropic amblyopia, best-corrected visual acuity of 20/32 to 20/63 in the amblyopic eye, interocular visual acuity difference of 2 or more lines, and no improvement in visual acuity in the amblyopic eye between 2 consecutive visits at least 6 weeks apart while patching 6 hours per day or using daily atropine. Spectacles, if prescribed (based on investigator discretion), met the criteria in eTable 1. All subjects wore spectacles except 4 with purely strabismic amblyopia. Additional eligibility criteria are listed in eTable 1. Subjects were randomized with equal probability to the following: (1) treatment with 6 hours of prescribed daily patching combined with daily atropine (intensive group); or (2) a reduction of current treatment for 4 weeks with 2 hours of prescribed daily patching or once-weekly atropine followed by spectacles alone if needed (weaning group). Randomization was accomplished using a permuted-blocks design stratified by site and by current treatment with patching or atropine. The primary outcome was masked assessment of visual acuity by isolated crowded Amblyopia Treatment Study HOTV (for subjects aged 3 to <7 years)3 or Electronic Early Treatment Diabetic Retinopathy Study (for subjects aged 7 to <10 years)4 optotypes at 10 weeks. Subjects in the intensive treatment group discontinued using atropine 2 weeks before this examination.
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