Safety and efficacy of using acupuncture as an adjunct to optical correction for amblyopia in children aged 3 to <7: a randomized controlled trial

INTERVENTION: 1:Refractive correction plus acupuncture: full‐time spectacle correction is prescribed to each subject. Acupuncture treatment 1 or 2 is given one time per day for 15 minutes each time, 5 times per week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX‐HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59). ;2:Children in Group 2 will receive Treatment 2 (optical correction and acupuncture 2 (non‐acupoint acupuncture);3:children in Group 3 will receive Treatment 3 (optical correction alone) for the first 30 weeks. Afterwards, children in three groups will be followed up for another 30 weeks. If the visual acuities of children in group 2 and 3 have remained stable for 10 weeks but not fulfill the criteria for resolution within the first 30 weeks, additional acupuncture will be prescribed.; CONDITION: Amblyopia PRIMARY OUTCOME: Best‐corrected visual acuity (BCVA) in the amblyopic eye at baseline and each follow‐up visit.; SECONDARY OUTCOME: BCVA in the sound eye. The proportion of patients with resolved amblyopia and responder rate. Other parameters, e.g., stereoacuity, axial length, RNFL and macular thickness measurements, weight, height measurement, where appropriate.; INCLUSION CRITERIA: 1. Aged 3 to <7; 2. Able to perform visual acuity using the ATS single‐surround HOTV protocol; 3. Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both: (1) Criteria for strabismus: At least one of the following criteria must be met: (2) Heterotropia at distance and/or near fixation on examination (with or without spectacles); (3) History of strabismus surgery (or botulinum); (4) Documented history of strabismus which is no longer present (and which in the judgment of the investigator is the cause of amblyopia); 4. Criteria for anisometropia : At least one of the following criteria must be met: (1) >=0.50 D difference between eyes in spherical equivalent; (2) 1.50 D difference between eyes in astigmatism in any meridian; 5. Criteria for combined mechanism amblyopia: Both of the following criteria must be met: (1) Criteria for strabismus are met (see above); (2) >=1.00 D differenc