Clinical Question: Does lutein supplementation improve vision in men with age-related macular degeneration?
Setting: Outpatient (specialty)
Study Design: Randomized controlled trial (double-blinded)
Allocation to Groups: Concealed
Synopsis: The authors of this study enrolled 90 patients (96 percent of whom were men) with an average age of 75 years and age-related macular degeneration, which had been diagnosed for an average of 4.5 years. The patients were randomized (allocation concealed) to receive lutein, an essential carotenoid pigment and antioxidant found in fruits and vegetables, in a dosage of 10 mg daily; lutein plus antioxidants, minerals, and other nutrients; or placebo, for 12 months.
Measured at four, eight, and 12 months, visual acuity improved by approximately one line on the eye chart (average: 5.4 Snellen equivalent letters) in the lutein-treated patients, improved somewhat less in the combination-treated group (3.5 Snellen equivalent letters), and decreased slightly in the placebo-treated patients. Glare recovery time, a measure of macular function, decreased significantly during the 12 months in the lutein-treated group, decreasing from 100 to 65 seconds in right eyes and from 80 to 60 seconds in left eyes (a glare recovery of less than 60 seconds is normal). Glare recovery times decreased similarly in the combination-treated group but decreased less with placebo (15- to 20-second decrease). Night driving was not affected in any of the groups.
Bottom Line: Supplementation with lutein in a dosage of 10 mg daily in men with age-related macular degeneration results in improved visual acuity. Antioxidant therapy does not offer an additional benefit. Other studies of antioxidant therapy generally have yielded no benefit, although a combination of antioxidants and zinc did show benefit ( Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol October 2001;119:1417–36). (Level of Evidence: 1b)