Adjunctive Effect of Acupuncture to Refractive Correction on Anisometropic Amblyopia One-Year Results of a Randomized Crossover Trial

Lam, D. S.

Zhao, J.

Chen, L. J.

Wang, Y.

Zheng, C.

Lin, Q.

Rao, S. K.

Fan, D. S.

Zhang, M.

Leung, P. C.

Ritch, R.

Ophthalmology

2011

RCT

RCT

Eye Diseases

Amblyopia, Anisometropic

Pilot Study

Cross-Over Design

Acu + Usual Care Versus Usual Care

Acupuncture

TCM Acupuncture Style

Fixed Acupuncture Protocol

Restricted Modalities, Acupuncture Only

Usual Care Control, Physical

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 x 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.

Eye Diseases

>1/WK

83

60 Weeks