Lutein ester supplementation preserved subfoveal choroidal thickness over six months in school-age children but did not slow axial elongation or refractive progression, according to a randomized controlled trial published in Translational Vision Science & Technology.
The double-blind, single-center study enrolled 180 children aged 8 to 12 years who were randomly assigned to receive either 8 mg of lutein ester daily or placebo for six months. The primary outcome was change in choroidal thickness (CT), measured using swept-source optical coherence tomography angiography across standard ETDRS grid locations.
After six months, children in the placebo group showed a mean reduction in subfoveal CT of −8.92 micrometers. In contrast, the supplementation group showed a mean change of 1.16 micrometers. The between-group difference was statistically significant at 10.08 micrometers. Similar patterns were observed in temporal regions of the macula.
Importantly, no significant differences were found between groups in axial length, spherical equivalent refraction, or central corneal thickness over the six-month period. The study therefore demonstrated an effect on a structural biomarker without measurable change in refractive progression or ocular growth during the study timeframe.
CT has been investigated as a potential early indicator of myopia progression. In this cohort, thinner subfoveal CT at baseline was associated with longer axial length and more myopic refractive error. However, the supplementation did not alter axial elongation or refractive error within six months.
This randomized controlled design provides data on what lutein ester supplementation appears to affect, and what it does not. The measurable change was in CT on OCT imaging, not in prescription or axial growth over the study period.
The study highlights the use of quantitative OCT biomarkers as endpoints in pediatric vision research. It also underscores the importance of distinguishing between structural changes and clinically meaningful refractive outcomes.
No adverse events were reported during the trial. Longer-term studies would be required to determine whether changes in CT translate into slower myopia progression. For now, this trial provides clinicians with data when discussing lutein ester supplementation with families seeking evidence-based guidance.
The researchers reported no conflicts of interest.
