Effect of Lutein Supplementation on VA Over a One-year Period in Early AMD
Investigators conducted a randomized, double-blind, placebo-controlled, two-center investigation to examine the effect of daily supplementation with lutein capsules on macular pigment optical density (MPOD) and visual acuity (VA) in patients with early age-related macular degeneration (AMD).
The trial took place at centers in Manchester, the United Kingdom and Maastricht, as well as the Netherlands, and lasted 12 months. The investigators randomly assigned 72 patients (mean age 70.5 ± 8.7) to either lutein capsules (10 mg Ester, n=36) or placebo (n=36) groups. Patients took lutein capsules or placebo daily. MPOD using a flicker-based technique (MPS9000) and best-corrected VA (LogMAR) were measured by investigators at the beginning and at four-month intervals over the duration of the supplementation period. Blood serum samples were collected to monitor compliance.
At the end of the trial, the study investigators observed an overall increase in the mean MPOD level for the lutein group from 0.38 ± 0.19 to 0.53 ± 0.22 optical density (OD) units. According to a mixed design ANOVA, this was statistically significant (p<0.001). No change in MPOD was found for the placebo group and there was no significant change in VA in the lutein group (n=36). The investigators noted that the placebo group (n=36) showed a statistically significant deterioration from 0.05 ± 0.13 to 0.09 ± 0.13 (p<0.05). When comparing the change in VA over the supplementation period, they found a significant difference between the two groups (p<0.05). To avoid ceiling effects, they reanalyzed two subgroups of patients with VA worse than 0.06 at baseline. In the lutein subgroup (n=19), they observed a mean improvement in VA from 0.23 ± 0.12 at baseline to 0.16 ± 0.10 at visit four (p<0.05). They also reported a small deterioration in the placebo subgroup (n=14) from 0.18 ± 0.13 to 0.19 ± 0.12 (p=0.70). They also compared the improvement in VA in the lutein subgroup to the deterioration in VA in the placebo group and this effect reached statistical significance (p<0.05).
Lutein supplementation increases MPOD levels in early stage AMD patients. According to the VA measurements, the progress of the disease might be slowed in some patients with augmented levels of MP.