Effect of Lutein Ester Supplement on Choroidal Thickness in Children: A Randomized Controlled Trial.

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.