Lutein/zeaxanthin for the treatment of age-related cataract: AREDS2 randomized trial report no. 4

Emily Y. Chew, John Paul SanGiovanni, Frederick L. Ferris, W. T. Wong, Elvira Agron, Traci E. Clemons, Robert Sperduto, Ronald Danis, Suresh R. Chandra, Barbara A. Blodi, Amitha Domalpally, Michael J. Elman, Andrew N. Antoszyk, Alan J. Ruby, David Orth, Susan B. Bressler, Gary E. Fish, George B. Hubbard, Michael L. Klein, Thomas R. FribergPhilip J. Rosenfeld, Cynthia A. Toth, Paul Bernstein

Research output: Contribution to journalArticlepeer-review

95 Scopus citations


Importance Age-related cataract is a leading cause of visual impairment in the United States. The prevalence of age-related cataract is increasing, with an estimated 30.1 million Americans likely to be affected by 2020. OBJECTIVE To determine whether daily oral supplementation with lutein/zeaxanthin affects the risk for cataract surgery. DESIGN, SETTING, AND PATIENTS The Age-Related Eye Disease Study 2 (AREDS2), a multicenter, double-masked clinical trial, enrolled 4203 participants, aged 50 to 85 years, at risk for progression to advanced age-related macular degeneration. INTERVENTIONS Participants were randomly assigned to daily placebo; lutein/zeaxanthin, 10mg/2mg; omega-3 long-chain polyunsaturated fatty acids, 1 g; or a combination to evaluate the effects on the primary outcome of progression to advanced age-related macular degeneration. MAIN OUTCOMES AND MEASURES Cataract surgerywas documented at annual study examination with the presence of pseudophakia or aphakia, or reported during telephone calls at 6-month intervals between study visits. Annual best-corrected visual acuity testing was performed. A secondary outcome of AREDS2 was to evaluate the effects of lutein/zeaxanthin on the subsequent need for cataract surgery. RESULTS A total of 3159 AREDS2 participants were phakic in at least 1 eye and 1389 of 6027 study eyes underwent cataract surgery during the study, with median follow-up of 4.7 years. The 5-year probability of progression to cataract surgery in the no lutein/zeaxanthin group was 24%. For lutein/zeaxanthin vs no lutein/zeaxanthin, the hazard ratios for progression to cataract surgery was 0.96 (95%CI, 0.84-1.10; P = .54). For participants in the lowest quintile of dietary intake of lutein/zeaxanthin, the hazard ratio comparing lutein/zeaxanthin vs no lutein/zeaxanthin for progression to cataract surgery was 0.68 (95%CI, 0.48-0.96; P = .03). The hazard ratio for 3 or more lines of vision loss was 1.03 (95%CI, 0.93-1.13; P = .61 for lutein/zeaxanthin vs no lutein/zeaxanthin). CONCLUSIONS AND RELEVANCE Daily supplementation with lutein/zeaxanthin had no statistically significant overall effect on rates of cataract surgery or vision loss.

Original languageEnglish (US)
Pages (from-to)843-850
Number of pages8
JournalJAMA ophthalmology
Issue number7
StatePublished - Jul 2013

ASJC Scopus subject areas

  • Ophthalmology


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