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ATS-2A: Patching 6 versus 12 hours for Severe Amblyopia
PEDIG, Holmes, J. M., Kraker, R. T., Beck, R. W., Birch, E. E., Cotter, S. A., et al. (2003). A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology, 110(11), 2075-2087.
OBJECTIVE: To compare full-time patching (all hours or all but 1 hour per day) to 6 hours of patching per day, as prescribed treatments for severe amblyopia in children younger than 7 years. DESIGN: Prospective, randomized multicenter clinical trial (32 sites). PARTICIPANTS: One hundred seventy-five children younger than 7 years with amblyopia in the range of 20/100 to 20/400. INTERVENTION: Randomization either to full-time patching or to 6 hours of patching per day, each combined with at least 1 hour of near-visual activities during patching. MAIN OUTCOME MEASURE: Visual acuity in the amblyopic eye after 4 months. RESULTS: Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the amblyopic eye acuity from baseline to 4 months averaged 4.8 lines in the 6-hour group and 4.7 lines in the full-time group (P = 0.45). CONCLUSION: Six hours of prescribed daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribed full-time patching in treating severe amblyopia in children 3 to less than 7 years of age.

ATS-2B: Patching 2 versus 6 hours for Moderate Amblyopia
PEDIG, Repka, M. X., Beck, R. W., Holmes, J. M., Birch, E. E., Chandler, D. L., et al. (2003). A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol, 121(5), 603-611.
OBJECTIVE: To compare 2 hours vs 6 hours of daily patching as treatments for moderate amblyopia in children younger than 7 years. METHODS: In a randomized multicenter (35 sites) clinical trial, 189 children younger than 7 years with amblyopia in the range of 20/40 to 20/80 were assigned to receive either 2 hours or 6 hours of daily patching combined with at least 1 hour per day of near visual activities during patching.Main Outcome Measure Visual acuity in the amblyopic eye after 4 months. RESULTS: Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the visual acuity of the amblyopic eye from baseline to 4 months averaged 2.40 lines in each group (P =.98). The 4-month visual acuity was at least 20/32 and/or improved from baseline by 3 or more lines in 62% of patients in each group (P>.99). CONCLUSION: When combined with prescribing 1 hour of near visual activities, 2 hours of daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by 6 hours of daily patching in treating moderate amblyopia in children aged 3 to 7 years.

ATS-2C: Recurrence 2 lines after cease patch or Atropine
PEDIG, Holmes, J. M., Beck, R. W., Kraker, R. T., Astle, W. F., Birch, E. E., et al. (2004). Risk of amblyopia recurrence after cessation of treatment. J Aapos, 8(5), 420-428.
BACKGROUND: Although amblyopia can be successfully treated with patching or atropine, there have been few prospective studies of amblyopia recurrence once treatment is discontinued. METHODS: We enrolled 156 children with successfully treated anisometropic or strabismic amblyopia (145 completed follow-up), who were younger than 8 years of age and who received continuous amblyopia treatment for the previous 3 months (prescribed at least 2 hours of daily patching or prescribed at least one drop of atropine per week) and who had improved at least 3 logMAR levels during the period of continuous treatment. Patients were followed off treatment for 52 weeks to assess recurrence of amblyopia, defined as a 2 or more logMAR level reduction of visual acuity from enrollment, confirmed by a second examination. Recurrence was also considered to have occurred if treatment was restarted because of a nonreplicated 2 or more logMAR level reduction of visual acuity. RESULTS: Recurrence occurred in 35 (24%) of 145 cases (95% confidence interval 17% to 32%) and was similar in patients who stopped patching (25%) and in patients who stopped atropine (21%). In patients treated with moderately intense patching (6 to 8 hours per day), recurrence was more common (11 of 26; 42%) when treatment was not reduced prior to cessation than when treatment was reduced to 2 hours per day prior to cessation (3 of 22; 14%, odds ratio 4.4, 95% confidence interval 1.0 to 18.7). CONCLUSIONS: Approximately one fourth of successfully treated amblyopic children experience a recurrence within the first year off treatment. For patients treated with 6 or more hours of daily patching, our data suggest that the risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced to 2 hours per day prior to cessation. A randomized clinical trial of no weaning versus weaning in successfully-treated amblyopia is warranted to confirm these observational findings.

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