Lutein Supplementation over a One-Year Period in Early AMD Might Have a Mild Beneficial Effect on Visual Acuity: The CLEAR Study.

PURPOSE. We investigated the effect of daily supplementation with lutein (L) capsules on macular pigment optical density (MPOD) and visual acuity (VA) in patients with early age-related macular degeneration (AMD).

METHODS. A randomized, double-blind, placebo-controlled, two-center investigation of the effects of L supplementation in early AMD was conducted. The duration of the trial was 12 months. The centers were Manchester, United Kingdom and Maastricht, the Netherlands. L capsules (10 mg Ester) or a placebo (P) were taken daily. There were 72 patients (mean age 70.5 +/- 8.7) assigned randomly to either L (n = 36) or P (n = 36) groups. MPOD using a flicker-based technique (MPS9000) and best corrected VA (LogMAR) were measured at the beginning and at 4-month intervals over the duration of the 12-month supplementation period. Blood serum samples were collected to monitor compliance.

RESULTS. At the end of the trial, an overall increase in the mean MPOD level was found for the L 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 P group. There was no significant change in VA in the L group (n = 36). The P 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, there was a significant difference between the two groups (P <0.05). To avoid ceiling effects, 2 subgroups of patients with VA worse than 0.06 at baseline were reanalyzed. In the L subgroup (n = 19) a mean improvement in VA from 0.23 +/- 0.12 at baseline to 0.16 +/- 0.10 at visit 4 was observed (P <0.05). In the P subgroup (n = 14), there was a small deterioration from 0.18 +/- 0.13 to 0.19 +/- 0.12 (P = 0.70). The improvement in VA in the L subgroup was compared to the deterioration in VA in the P group and this effect reached statistical significance (P <0.05).

CONCLUSIONS. L 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. (ClinicalTrials. gov number NCT01042860.) (Invest Ophthalmol Vis Sci. 2013;54:1781-1788) DOI:10.1167/iovs.12-10715