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

Lutein ester supplementation significantly mitigated subfoveal choroidal thinning over six months compared to placebo.

• The six-month mean subfoveal CT change was -1.16 (-3.32 to 5.63) µm for the treatment group versus -8.92 (-13.43 to -4.41) µm for the control group.
• Mean difference of 10.08 µm (95% CI, 3.68 to 16.47, P = 0.002, corrected P = 0.018).
• 180 children aged 8 to 12 years were enrolled; 90 in the treatment group and 90 in the control group.
• Treatment consisted of one sachet with 8 mg lutein ester consumed orally daily for six months.

Lutein ester supplementation significantly mitigated temporal choroidal thinning at 1 mm and 1.5 mm from the fovea.

• Mean temporal 1 mm CT change was -2.83 (-9.63 to 3.96) µm in the treatment group versus -16.76 (-24.20 to -9.33) µm in the control group; mean difference of 13.93 µm (95% CI, 3.79–24.07, P = 0.007, corrected P = 0.030).
• Mean temporal 1.5 mm CT change was -1.24 (-9.64 to 7.15) µm in the treatment group versus -15.77 (-22.67 to -8.88) µm in the control group; mean difference of 14.53 µm (95% CI, 3.59–25.47, P = 0.010, corrected P = 0.030).
• These were statistically significant after correction for multiple comparisons.

No statistically significant between-group differences in choroidal thickness were found at other macular grid locations.

• The two groups were not significantly different in other grids (all P > 0.05).
• Significant effects were limited to subfoveal and temporal (1 mm and 1.5 mm) regions.

The study was a double-blind randomized controlled trial conducted in a school setting with a six-month follow-up.

• 180 children aged 8 to 12 years were recruited from a school from April to May 2021, with follow-up completed in November 2021.
• Participants were randomly assigned 1:1 to treatment (8 mg lutein ester sachet daily) or control (placebo sachet daily).
• Primary outcomes were between-group differences in changes in CT at six-month follow-up visits.

The authors highlight lutein ester's favorable safety profile, affordability, and global availability as supporting its potential as an adjunctive nutritional strategy for myopia prevention and management.

• The paper notes lutein's 'favorable safety, affordability, and global availability.'
• The authors describe lutein supplementation as having 'untapped potential as a promising, adjunctive nutritional strategy to support clinical efforts in myopia prevention and management.'
• Choroidal thinning is implicated in myopia development, providing the rationale for using CT as a primary outcome.