Changes following supplementation with lutein and zeaxanthin in retinal function in eyes with early age-related macular degeneration: a randomised, double-blind, placebo-controlled trial
What this study found
Supplementation increased macular pigment optical density (MPOD) in the active groups, and lutein improved retinal sensitivity. MPOD rose significantly in active arms, with values at 2 years of 0.442±0.127 for 10 mg lutein, 0.441±0.133 for 20 mg lutein, and 0.383±0.149 for lutein plus zeaxanthin. At 2 years, macular retinal sensitivity at 1° eccentricity was higher than placebo (10.32 dB) in the 10 mg lutein group (13.37 dB) and 20 mg lutein group (12.55 dB), with p<0.05. The 20 mg lutein group also showed a 32.8% increase in ring 2 density at 48 weeks (p<0.05), while rings 3-6 did not…
- Study & population
- Randomized, double-blind, placebo-controlled trial in adults with early age-related macular degeneration recruited in Beijing, China.
- Intervention
- Participants received oral capsules for 2 years containing 10 mg lutein daily, 20 mg lutein daily, or lutein 10 mg plus zeaxanthin 10 mg daily, compared with placebo.
- Key limitation
- The trial had modest per-arm sample sizes and was conducted at a single center in Beijing, which limits generalizability.
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Open PDFOriginal abstract
Aims To investigate functional and macular pigment (MP) changes in patients with early age-related macular degeneration (AMD) after multiple supplementation with lutein and zeaxanthin. Methods 112 patients with early AMD were randomly (1:1:1:1) assigned to receive 10 mg lutein, 20 mg lutein, lutein (10 mg)+zeaxanthin (10 mg), or placebo daily for 2 years. MP optical density (MPOD) was recorded at baseline, 48 weeks and 2 years. Retinal sensitivities were measured by multifocal electroretinogram for peak-to-trough amplitude (N1P1) at baseline and at 48 weeks, and in terms of microperimeter-determined mean retinal sensitivity (MRS) at 48 weeks and 2 years. Results Supplementation with lutein and zeaxanthin augmented MPOD significantly in active treatment groups (all p<0.05). N1P1 response densities showed significant increases in ring 1 and ring 2 after 48 weeks of supplementation, while no significant changes were seen in rings 3–6. Significant increases in MRS were detected after supplementation with either 10 or 20 mg lutein, whereas no such increases were seen in the placebo arm. Conclusions Supplementation with lutein and/or zeaxanthin increases MPOD, and supplemental lutein enhances retinal sensitivity, in patients with early AMD. Trial registration number Clinicaltrials.gov NCT10528605.