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Clinical Trials |

Randomized Controlled Trial of Patching vs Acupuncture for Anisometropic Amblyopia in Children Aged 7 to 12 Years

Jianhao Zhao, MD; Dennis S. C. Lam, MD, FRCOphth; Li Jia Chen, PhD; Yunxiu Wang, BMed; Chongren Zheng, DEpid; Qiaoer Lin, DN; Srinivas K. Rao, FRCS; Dorothy S. P. Fan, FRCS; Mingzhi Zhang, MD; Ping Chung Leung, MD; Robert Ritch, MD, FRCOphth
Arch Ophthalmol. 2010;128(12):1510-1517. doi:10.1001/archophthalmol.2010.306.
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Objective  To compare the effectiveness of 2-hour daily patching with the effectiveness of acupuncture in treating anisometropic amblyopia in children aged 7 to 12 years who have worn optimal spectacles for at least 16 weeks.

Methods  In a single-center randomized controlled trial, 88 eligible children with an amblyopic eye who had a best spectacle-corrected visual acuity (BSCVA) of 0.3 to 0.8 logMAR at baseline were randomly assigned to receive 2 hours of patching of the sound eye daily or 5 sessions of acupuncture weekly. All participants in our study received constant optical correction, plus 1 hour of near-vision activities daily, and were followed up at weeks 5, 10, 15, and 25. The main outcome measure was BSCVA in the amblyopic eye at 15 weeks.

Results  The mean BSCVA of the amblyopic eye at 15 weeks improved from baseline by 1.83 and 2.27 lines in the patching and acupuncture groups, respectively. After baseline adjustment, the mean difference of BSCVA between the 2 groups was 0.049 logMAR (95% confidence interval, 0.005-0.092; P = .03), meeting the definition of equivalence (difference within 1 line). The BSCVA had improved by 2 lines or more in 28 (66.7%) and 31 (75.6%) eyes in the patching and acupuncture groups, respectively. Amblyopia was resolved in 7 (16.7%) and 17 (41.5%) eyes in the patching and acupuncture groups, respectively.

Conclusion  Acupuncture produced equivalent treatment effect for anisometropic amblyopia, compared with patching, and was statistically superior. Further studies are warranted to investigate its value in the treatment of amblyopia.

Clinical Relevance  Acupuncture could potentially become an alternative treatment to occlusion therapy for amblyopia.

Trial Registration  Centers for Clinical Trials Registry Identifier: CUHK_CCT00248

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Figure 1.

Schematic diagram showing the positions of the acupoints used in this study and photographs showing children receiving acupuncture. A-D, 5 Acupoints: unilateral GV20 (baihui) (A), bilateral BL2 (cuanzhu) and bilateral EX-HN5 (taiyang) (B), unilateral LI4 (hegu) (C), and bilateral BL59 (fuyang) (D). The arrows indicate the acupoints.

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Figure 2.

Flowchart showing the progress of participants in each treatment group of our randomized controlled trial. The term not improved is defined as a lack of improvement in visual acuity (VA) of the amblyopic eye for at least 1 logMAR line from baseline. An improvement of 1 line or more is defined as improvement in the VA of the amblyopic eye of 1 line or more than the baseline VA score.

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