Human research · RCT
Dong J et al., Ophthalmology 2023; Clinical & Experimental Ophthalmology 2022
Landmark T02 #1, what came after (1): replication and a sham-controlled trial. Two primary follow-ups I read in full. (1) Dong J, Zhu Z, Xu H, He M, Ophthalmology 2023 (PMID 36049646) - the first double-masked, SHAM-controlled RLRL RCT; 112 Chinese children 7-12, 6 months, same Eyerising device at 100% vs a sham at 10% power: the 100%-power group beat sham on the primary outcome (SER change +0.06 D vs -0.11 D, P=0.003) and on axial length (+0.02 mm vs +0.13 mm, P<0.001), so benefit survives masking - but the 10%-power 'sham' itself progressed less than historical spectacle controls, hinting even low-power light may act. (2) Xiong R et al., Clin Exp Ophthalmol 2022 (PMC10086781) - the 2-year post-trial, NON-randomised follow-up of the NCT04073238 cohort: continued RLRL kept the best control over 2 years (axial 0.16 mm vs 0.64 mm for spectacles-only, 75.0% efficacy), but STOPPING RLRL produced a rebound - second-year axial elongation was 0.42 mm, FASTER than the 0.28 mm seen the same year in never-treated children (authors call it a 'modest rebound'; 2-year cumulative RLRL-SVS 0.50 vs SVS-SVS 0.64 mm).
Source: Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Ophthalmology. 2022;129(5):509-519. doi:10.1016/j.ophtha.2021.11.023. PMID 34863776. Published online 2021-12-01. ClinicalTrials.gov NCT04073238.
Verified research card EL-LM-T02-01-c-R6