A randomized controlled trial on the effect of Lutein Supplementation on Macular Pigment Optical Density and Macular Function in Pseudophakic Patients

ABSTRACT

Objective@#To evaluate the efficacy of oral lutein supplementation on macular pigment optical density (MPOD) levels and macular function in pseudophakic eyes that underwent phacoemulsification. @*Methods@#This was a prospective, randomized, parallel-arm, single-masked study comparing oral lutein supplement 20 mg/tablet (Lutax 20) with non-supplementation in pseudophakic eyes. We assessed MPOD, low-luminance deficit (LLD), visual recovery time (VRT) using photostress test, and adverse events. One hundred twenty-eight (128) eyes were enrolled and randomized 11 to active treatment (lutein supplementation) or no treatment (no supplementation). The supplementation period was 12 weeks and patients were assessed every 4 weeks over a period of 16 weeks.@*Results@#Sixty-four (64) eyes in each group completed the study. A significant increase in MPOD (p<0.001) was observed in the lutein supplemented group, from 0.36 DU at baseline to 0.55 DU at week 12, with a mean increase of 6.32 ± 1.72% per 4 weeks of supplementation compared with a mean MPOD decrease rate of 0.63 ± 0.48% in the non-supplementation group. A significant reduction in LLD was observed in the lutein-treated group, from LogMAR 0.063 at baseline to LogMAR 0.023 at Week 12 (p=0.003). VRT was also significantly shorter in the treatment from a baseline of 83.06 to 68.80 seconds at Week 12 (p<0.001).@*Conclusion@#Lutein supplementation (20 mg/tablet; Lutax 20) demonstrated a significant degree of MPOD augmentation, and reductions in LLD and VRT among patients who underwent phacoemulsification with lens implantation.