Original Investigation | Clinical Trial

Lutein/Zeaxanthin for the Treatment of Age-Related Cataract:  AREDS2 Randomized Trial Report No. 4

The Age-Related Eye Disease Study 2 (AREDS2) Research Group; Emily Y. Chew, MD, chair1; John Paul SanGiovanni, ScD1; Frederick L. Ferris, III, MD1; Wai T. Wong, MD, PhD1; Elvira Agron, MA1; Traci E. Clemons, PhD2; Robert Sperduto, MD2; Ronald Danis, MD3; Suresh R. Chandra, MD3; Barbara A. Blodi, MD3; Amitha Domalpally, MD3; Michael J. Elman, MD4; Andrew N. Antoszyk, MD5; Alan J. Ruby, MD6; David Orth, MD7; Susan B. Bressler, MD8; Gary E. Fish, MD9; George B. Hubbard, M10; Michael L. Klein, MD11; Thomas R. Friberg, MD12; Philip J. Rosenfeld, MD, PhD13; Cynthia A. Toth, MD14; Paul Bernstein, MD, PhD15
[+] Author Affiliations
1National Eye Institute/National Institutes of Health, Bethesda, Maryland
2EMMES Corp, Rockville, Maryland
3University of Wisconsin, Madison, Wisconsin
4Elman Retina Group PA, Baltimore, Maryland
5Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina
6Vision Research Foundation, Royal Oak, Michigan
7Ingalls Memorial Hospital, Harvey, Illinois
8Retina Division at Wilmer Eye Institute, Baltimore, Maryland
9Texas Retina Associates, Dallas, Texas
10Emory University Eye Center, Atlanta, Georgia
11Devers Eye Institute, Portland, Oregon
12University of Pittsburgh Medical Center Eye Center, Pittsburgh, Pennsylvania
13Bascom Palmer Eye Institute, Miami, Florida
14Duke University, Durham, North Carolina
15University of Utah (Moran Eye Center), Salt Lake City, Utah
JAMA Ophthalmol. 2013;131(7):843-850. doi:10.1001/jamaophthalmol.2013.4412.
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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 surgery was 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.

Trial Registration  clinicaltrials.gov Identifier: NCT00345176.

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Figure 1.
Flow Diagram of Participants in the Age-Related Eye Disease Study 2 of Lutein/Zeaxanthin Treatment for Age-Related Cataract

DHA indicates docosahexaenoic acid; EPA, eicosapentaenoic acid.

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Figure 2.
Progression to Cataract Surgery in Age-Related Eye Disease Study 2 Participants by Treatment (Lutein/Zeaxanthin vs No Lutein/Zeaxanthin)
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Figure 3.
Effect of Lutein/Zeaxanthin Supplementation on the Progression of Cataract Stratified by Dietary Intake of Lutein/Zeaxanthin
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Figure 4.
Effect of Lutein/Zeaxanthin Supplementation on Moderate Vision Loss (3 or More Lines) From Baseline Stratified by Dietary Intake of Lutein/Zeaxanthin

IQR indicates interquartile range.

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