Effect of lutein and antioxidant dietary supplementation on contrast sensitivity in age-related macular disease: a randomized controlled trial

Randomized controlled trial conducted in the United Kingdom among adults with age-related maculopathy or atrophic age-related macular degeneration. In the active supplement group, 15 participants were randomized and 13 were analyzed; the cohort was White British, aged 55 to 82 years, with recruitment from Aston University and a UK optometric clinical practice.

Participants in the active arm took 1 oral tablet daily with food for 9 months. Each tablet contained lutein esters 6 mg, retinol 750 mg, vitamin C 250 mg, vitamin E 34 mg, zinc 10 mg, and copper 0.5 mg, compared with placebo.

Daily lutein and antioxidant supplementation for 9 months did not improve contrast sensitivity in ARM-affected eyes compared with placebo. Baseline contrast sensitivity was similar between groups, and the 9-month change was +0.07 log units in placebo versus -0.02 log units in the active group. The between-group difference was not significant (z = -0.903, P = 0.376). Although placebo showed a small within-group improvement (P = 0.03), the active supplement did not show a meaningful benefit, and no adverse events were reported.

The active arm was small, with only 13 analyzed participants, and the trial had short follow-up of 9 months. The sample was restricted to White British participants in one country, limiting generalizability, and only a single primary visual outcome was reported. Dietary intake differed somewhat between groups, which could add noise to interpretation.