Tongtong Li, Jing Li, Chaoming Deng, Fan Yang, J. Ran, E. Wang, Wei Qin, Mengtong Yang, Xiangyun Li, Li Li, Di Wang, Haiyan Wang, Ziyi Xu, Yanjun Guo, Anqi Wang, Wenli Lu, Zhongxia Li, Xuehan Qian, Jing Yan
Purpose: To assess the effect of a six-month lutein ester supplementation on children's choroidal thickness (CT). Methods: This double-blind, randomized controlled trial recruited 180 children aged eight to twelve years in a school from April to May 2021. The follow-up was completed in November 2021. Participants were randomly assigned to the treatment group (n = 90, one sachet with 8 mg lutein ester) or the control group (n = 90, one placebo sachet). Each participant consumed one sachet daily orally for six months. Primary outcomes were between-group differences in changes in CT at six-month follow-up visits. Results: The six-month mean subfoveal CT decrease was 1.16 (-3.32 to 5.63) µm for the treatment group and -8.92 (-13.43 to -4.41) µm for the control group, with a mean difference of 10.08 µm (95% confidence interval [CI], 3.68 to 16.47, P = 0.002, corrected P = 0.018). The six-month mean temporal 1 mm and temporal 1.5 mm CTs decrease were -2.83 (-9.63 to 3.96) µm and -1.24 (-9.64 to 7.15) µm for the treatment group and -16.76 (-24.20 to -9.33) µm and -15.77 (-22.67 to -8.88) µm for the control group, with mean differences of 13.93 µm (95% CI, 3.79-24.07, P = 0.007, corrected P = 0.030) and 14.53 µm (95% CI, 3.59-25.47, P = 0.010, corrected P = 0.030), respectively. The two groups were not significantly different in the other grids (all P > 0.05). Conclusions: Six-month lutein ester supplementation could effectively mitigate subfoveal and temporal choroidal thinning. Translational Relevance: Given lutein's favorable safety, affordability, and global availability, our study highlights its untapped potential as a promising, adjunctive nutritional strategy to support clinical efforts in myopia prevention and management.