OBJECTIVES: To evaluate the safety and adjunctive effect of acupuncture added to refractive correction for anisometropic amblyopia in younger children. DESIGN: Prospective, randomized, controlled, crossover trial. PARTICIPANTS: We included 83 children aged 3 to <7 years with untreated anisometropic amblyopia and baseline best-corrected visual acuity (BCVA) of 20/40 to 20/200 in the amblyopic eye. METHODS: Participants were randomized to receive spectacles alone (group 1; n = 42) or spectacles + acupuncture (group 2; n = 41) for 15 weeks, and were then crossed over to receive the other regimen for another 15 weeks. The BCVA in both eyes was measured at baseline and every 5 (±1) weeks for the initial 45 weeks and at 60 (±1) weeks. MAIN OUTCOME MEASURES: BCVA in the amblyopic eye at 15, 30, and 60 weeks. RESULTS: The mean baseline BCVA in the amblyopic eye was 0.50 and 0.49 logarithm of the minimum angle of resolution (logMAR) in groups 1 and 2, respectively. After 15 weeks of treatment, the BCVA had improved by a mean of 2.2 lines in group 1 and 2.9 lines in group 2. The mean difference in BCVA between groups was 0.77 lines (95% confidence interval (CI), 0.29-1.3; P = 0.0020) with baseline adjustment. BCVA of ≤0.1 logMAR was achieved in 14.6% of the patients in group 1 and 57.5% in group 2 (P<0.00010). After the regimens were crossed over at 30 weeks, group 1 had a mean of 1.2 (95% CI, 0.98-1.48; P = 2.0 × 10⁻¹²) lines additional improvement from the 15-week BCVA, whereas in group 2 the mean improvement was 0.4 (95% CI, 0.19-0.63; P = 0.0010) lines. The proportions of responders, resolution, and participants achieving a BCVA of ≤0.1 logMAR at 30 weeks were similar between groups. After completion of acupuncture, only 1 participant had >1 line of VA decrease to 60 weeks. Acupuncture was well-tolerated by all children, and no severe adverse effect was encountered. CONCLUSIONS:Acupuncture is a potentially useful complementary treatment modality that may provide sustainable adjunctive effect to refractive correction for anisometropic amblyopia in young children. Further large-scale studies seem warranted. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
RCT Entities:
OBJECTIVES: To evaluate the safety and adjunctive effect of acupuncture added to refractive correction for anisometropic amblyopia in younger children. DESIGN: Prospective, randomized, controlled, crossover trial. PARTICIPANTS: We included 83 children aged 3 to <7 years with untreated anisometropic amblyopia and baseline best-corrected visual acuity (BCVA) of 20/40 to 20/200 in the amblyopic eye. METHODS:Participants were randomized to receive spectacles alone (group 1; n = 42) or spectacles + acupuncture (group 2; n = 41) for 15 weeks, and were then crossed over to receive the other regimen for another 15 weeks. The BCVA in both eyes was measured at baseline and every 5 (±1) weeks for the initial 45 weeks and at 60 (±1) weeks. MAIN OUTCOME MEASURES: BCVA in the amblyopic eye at 15, 30, and 60 weeks. RESULTS: The mean baseline BCVA in the amblyopic eye was 0.50 and 0.49 logarithm of the minimum angle of resolution (logMAR) in groups 1 and 2, respectively. After 15 weeks of treatment, the BCVA had improved by a mean of 2.2 lines in group 1 and 2.9 lines in group 2. The mean difference in BCVA between groups was 0.77 lines (95% confidence interval (CI), 0.29-1.3; P = 0.0020) with baseline adjustment. BCVA of ≤0.1 logMAR was achieved in 14.6% of the patients in group 1 and 57.5% in group 2 (P<0.00010). After the regimens were crossed over at 30 weeks, group 1 had a mean of 1.2 (95% CI, 0.98-1.48; P = 2.0 × 10⁻¹²) lines additional improvement from the 15-week BCVA, whereas in group 2 the mean improvement was 0.4 (95% CI, 0.19-0.63; P = 0.0010) lines. The proportions of responders, resolution, and participants achieving a BCVA of ≤0.1 logMAR at 30 weeks were similar between groups. After completion of acupuncture, only 1 participant had >1 line of VA decrease to 60 weeks. Acupuncture was well-tolerated by all children, and no severe adverse effect was encountered. CONCLUSIONS: Acupuncture is a potentially useful complementary treatment modality that may provide sustainable adjunctive effect to refractive correction for anisometropic amblyopia in young children. Further large-scale studies seem warranted. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.