- 2025-12-01
- Translational vision science & technology 14(12)
- Tongtong Li
- Jing Li
- Chaoming Deng
- Fan Yang
- Jingjing Ran
- Enming 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
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 180
- Population
- 180 children aged eight to twelve years
- Methods
- Double-blind, randomized controlled trial; participants randomly assigned to treatment group (one sachet with 8 mg lutein ester) or control group (one placebo sachet), consumed one sachet daily orally for six months
- Blinding
- Double-blind
- Duration
- six months
- Funding
- Unclear
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.