Abstract
INTRODUCTION: Lutein supplementation is beneficial in preventing maculae from developing serious ocular diseases. This study aimed to evaluate the efficacy and safety of lutein administration in patients with high myopia (HM). METHODS: In a single-center randomized double-blinded placebo-controlled trial conducted over 24 months, 22 eyes were enrolled in lutein and control groups. Among them, 15 eyes in the lutein group and 13 eyes in the control group completed the study. All patients with HM (axial length > 26.00) were administered lutein (20 mg) or placebo once daily for 6 months. The macular pigment optical density (MPOD), rate of change in MPOD, visual acuity, contrast sensitivity, and electroretinogram after administration were examined at baseline, 3 months, and 6 months. RESULTS: The baseline MPOD in the control and lutein groups was 0.71 ± 0.21 and 0.70 ± 0.22, respectively. The MPOD in the control and lutein groups at 3 months was 0.70 ± 0.21 and 0.70 ± 0.25, respectively, and at 6 months was 0.66 ± 0.20 and 0.72 ± 0.27, respectively, which was not significantly different from those at baseline or between the groups. The MPOD significantly increased from baseline in the lutein group with less than 28.25 mm of axial length at 6 months (from 0.71 ± 0.20 to 0.78 ± 0.22, P = .02, t test). visual acuity, contrast sensitivity, and electroretinogram values were similar between the groups. CONCLUSION: Lutein supplementation showed significant benefits in MPOD augmentation in patients with HM.