Dietary Supplement for Myopia Control

Myopia commonly develops in childhood and is projected to affect nearly half of the global population by 2050, with high myopia posing a significant risk for irreversible vision loss. Although existing interventions can slow myopia progression, their use is limited by safety concerns, discomfort, variable efficacy, and accessibility, particularly in children. Therefore, exploring safe and accessible dietary oral supplements represents a promising alternative strategy for myopia control.

This study aims to conduct a 3-month, double-blind, placebo-controlled randomized clinical trial in myopic children to evaluate the effects of a specific dietary supplement on choroidal structure and vasculature and to explore its potential role in myopia control. The trial will compare changes in subfoveal and average choroidal thickness (ChT), choroidal vascularity index (CVI), axial length (AL), and spherical equivalent refraction (SER) among high-dose, low-dose, and placebo groups, assess the efficacy and safety of the combined supplementation. Subfoveal and average ChT, AL, visual acuity, cycloplegic SER, slit lamp, swept-source optical coherence tomography /angiography will be measured at 1-, 2-, and 3-month follow-up visits.

Inclusion criteria

• Age 8-13 years
• Cycloplegic spherical equivalent refraction (SER) of -0.50 D to -5.00 D with astigmatism of 2.5 D or less and best-corrected visual acuity (BCVA) of 0.0 logarithm or more in either eye
• Anisometropia of 1.50 D or less
• Intraocular pressure of 10 mmHg to 21 mmHg in both eyes
• Willing to give written consent to participate in the study and accept random allocation in grouping

Exclusion criteria

• Ocular abnormalities leading to visual impairment
• Severe physiological and psychological diseases affecting follow-up
• Receiving previous myopia control treatment including but not limited to atropine therapy and orthokeratology in the past 3 months
• Use of any other dietary supplements containing DHA/EPA, Lutein, or Astaxanthin in the past 3 months
• Known history of allergy to any of the components of the dietary supplement or placebo, or history of an allergic reaction that required emergency treatment
• Children who had other contraindications identified by the investigators that made them unsuitable for participation