TABLE 8

RCTs of Amblyopia Treatments

PopulationFollow-upIntervention: Mean Change in logMAR Visual Acuity From BaselineQuality Rating
Patching + eyeglasses vs eyeglasses alone vs no treatment
    Clarke et al72 (2003)n = 177; mean age 4.0 y; mean logMAR visual acuity in worse eye 0.36 (approximate Snellen equivalent 20/45)1 yPatching (hours/day not reported) + eyeglasses: 0.18; mean difference vs no treatment: 0.109 (95% CI: 0.005 to 0.17); eyeglasses only: 0.13; mean difference vs no treatment: 0.085 (95% CI: 0.02 to 0.15); no treatment: 0.06; P = .001 (ANOVA)
Results stratified according to baseline severity; mild acuity loss at baseline: patching + eyeglasses: 0.23; mean difference vs no treatment: 0.04 (95% CI: −0.06 to 0.13); eyeglasses only: 0.24; mean difference vs no treatment 0.05 (95% CI: −0.03 to 0.13); no treatment: 0.19; P = .38 (ANOVA); moderate acuity loss at baseline: patching + eyeglasses: 0.52; mean difference vs no treatment: 0.27 (95% CI: 0.14 to 0.39); eyeglasses only: 0.35; mean difference vs no treatment: 0.11 (95% CI: −0.03 vs 0.24); no treatment: 0.25; P <.001 (ANOVA)
Good
Patching vs no patching, all children pretreated with eyeglasses if indicated
    Awan et al73 (2005)n = 60; mean age 4.6 y; mean logMAR visual acuity amblyopic eye 0.64 (approximate Snellen equivalent 20/90); 55/60 (92%) received eyeglasses for correction of refractive error12 wk3-h patching: 0.29 (P = .32 vs no treatment); 6-h patching: 0.34 (P = .09 vs no treatment); no treatment: 0.24 (P = .11 vs both treatments)Fair
    PEDIG74 (2006)n = 180; mean age 5.3 y; mean logMAR visual acuity amblyopic eye 0.55 (approximate Snellen equivalent 20/70); 155/180 (86%) received eyeglasses for correction of refractive error5 wk2-h patching: 0.12; no treatment: 0.04; mean between-group difference: 0.07 (95% CI: 0.02 to 0.12; P = .006)Good
Occlusion regimens
    PEDIG75 (2003)n = 189; mean age 5.2 y; mean logMAR visual acuity amblyopic eye 0.48 (approximate Snellen equivalent 20/63)4 mo2-h patching: 0.24; 6-h patching: 0.24; mean between-group difference: 0.001 (95% CI: 0.040 to 0.042; P = .9)Good
    Stewart et al76 (2007)n = 97; mean age 5.6 y; mean logMAR visual acuity amblyopic eye 0.44 (approximate Snellen equivalent 20/70)Mean: 9 wk (range: 5–26)6-h patching: 0.26; 12-h patching: 0.24; mean between-group difference: 0.02 (95% CI: 0.0 to 0.04; P = .64)Fair
Atropine regimens
    PEDIG77 (2004)n = 168; mean age 5.3 y; mean logMAR visual acuity amblyopic eye 0.46 (approximate Snellen equivalent 20/60)4 moDaily atropine: 0.23; weekend atropine: 0.25; mean between-group difference: 0.02 (95% CI: −0.21 to 0.09; P = .52)Good
Patching vs atropine
    PEDIG78 (2002)n = 419; mean age 5.3 y; mean logMAR visual acuity amblyopic eye 0.53 (approx Snellen equivalent 20/65)Initial trial: 6 mo; voluntary follow-up up to age 10 y6-mo results: mean age 5.2 y; patching 0.25; atropine 0.21; mean between-group difference 0.04 (95% CI: 0.005 to 0.064)
2-y results: mean age 7.2 y; follow-up of 363/419 (86.6%) of patients in original study; patching 0.16; atropine 0.17; mean between-group difference 0.01 (95% CI: −0.04 to 0.02; P = .57)
5-y results: mean age 10.3 y; follow-up of 176/419 (42.0%) of patients in original study; patching 0.19; atropine 0.16; mean between-group difference 0.03 (95% CI: −0.02 to 0.07; P = .2)
Good
  • ANOVA indicates analysis of variance.