Abstract
Purpose: :
To determine the effect on photopic (visual acuity) and scotopic (dark adaptation) vision of enhancing macular pigment optical density (MPOD) with lutein (L) capsules in patients with early AMD.
Methods: :
A randomised, placebo-controlled two-centred, 12 month study of the effects of L supplementation was conducted in Manchester, UK and Maastricht, The Netherlands. L capsules (10mg Ester), or a placebo were taken daily. 71 patients were randomly assigned to either L (lutein, n=34, mean age 71.7 ± 8.7 ) or P (placebo, n=37, mean age 69.1 ± 8.5) groups. Best corrected Log MAR visual acuities, dark adaptation and MPOD were measured at baseline and on three, four month intervals, after the start of the 12 month supplementation period. MPOD was measured using a flicker-based technique. VA data were analysed only for patients with VA>0.06 (L group n=19, P group n=16).
Results: :
MPOD increased from 0.38 ± 0.19 to 0.53 ± 0.22 OD units (p0.06, VA improved from 0.23 ± 0.12 (baseline) to 0.16 ± 0.10 (visit 4) in the L group (p=0.004). In the P group there was a non-significant deterioration in VA from 0.18 ± 0.12 to 0.20 ± 0.12. The mean difference in VA between baseline and visit 4 for the L group was 0.07 ± 0.10 and for the P group was -0.03 ± 0.10 (p<0.001). The mean rod recovery rate for the L group was 3.1 ± 1.1 dB/min at baseline and this increased to 3.7 ± 1.7 dB/min at visit 4 (p=0.017). The mean rod recovery rate for the P group was reduced from 3.3 ±1.3 dB/min to 3.1 ±1.35 dB/min (NS).
Conclusions: :
Lutein supplementation over a 12 months period increased MPOD levels in AMD patients. In some, but not all patients, this increase in MPOD was accompanied by an improvement in VA. In those with VA>0.06, 56% improved VA by more than 1 line.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01042860
Keywords: macular pigment • age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials