AREDS2
Trial question
What is the role of supplementation of lutein/zeaxanthin in older adults with age-related cataract?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 1562
1562 patients (849 female, 713 male).
Inclusion criteria: patients aged 50-85 years with age-related cataract at risk for progression to advanced age-related macular degeneration.
Key exclusion criteria: other ocular diseases that might confound assessment of the ocular outcomes; other systemic diseases including lung cancer; other diseases associated with poor 5-year survival; previous cataract surgery in < 3 months prior enrollment.
Interventions
N=787 lutein/zeaxanthin (daily oral dose of 10 mg/2 mg).
N=775 placebo (matching placebo).
Primary outcome
Progression to cataract surgery at 5 years
24%
24%
24.0 %
18.0 %
12.0 %
6.0 %
0.0 %
Lutein/zeaxanthin
Placebo
No significant
difference ↔
No significant difference in progression to cataract surgery at 5 years (24% vs. 24%; HR 0.96, 96% CI 0.84 to 1.1).
Secondary outcomes
No significant difference in development of any cataract (29.5% vs. 31.3%; HR 0.93, 95% CI 0.83 to 1.04).
No significant difference in development of any severe cataract (24.3% vs. 25.6%; HR 0.94, 95% CI 0.83 to 1.07).
No significant difference in moderate or worse vision loss (35% vs. 34.5%; HR 1.03, 95% CI 0.93 to 1.13).
Safety outcomes
No significant difference in serious adverse events and death.
Conclusion
In patients aged 50-85 years with age-related cataract at risk for progression to advanced age-related macular degeneration, lutein/zeaxanthin was not superior to placebo with respect to progression to cataract surgery at 5 years.
Reference
Age-Related Eye Disease Study- (AREDS) Research Group, Emily Y Chew, John Paul SanGiovanni et al. Lutein / zeaxanthin for the treatment of age-related cataract: AREDS2 randomized trial report no. 4. JAMA Ophthalmol. 2013 Jul;131(7):843-50.
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