Human research · RCT
Jiang Y et al., Ophthalmology, 2022
Landmark T02 #1, methods and limits (registry and funding/COI check). This RCT (NCT04073238) pre-registered axial length as its single primary outcome, with SER and other biometry/visual acuity as secondaries; the current registry record and protocol v.7 (May 2019) match the paper on these. Registration was retrospective by about 26 days (first submitted 2019-08-18; actual start 2019-07-23). The device maker (Suzhou Xuanjia Optoelectronics / Eyerising) provided devices free and, per the paper, gave no research funding; its system also ran compliance monitoring. The paper discloses a device patent for Z.Z. and M.H.; M.H.'s later papers disclose a director/equity role in Eyerising. The biggest design weakness is the absence of a sham control.
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-b-R1