Antioxidants for Prevention of Cataracts Follow-up Study
Aravind Eye Hospital and the University of California, San Francisco (UCSF) Proctor Foundation collaborated on the Antioxidants for the Prevention of Cataract Study from 1997-2002. (1) In the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) or placebo. After 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. In this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups.
1. Gritz DC, Srinivasan M, Smith SD, et al. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. The British journal of ophthalmology 2006;90:847-51.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Antioxidants for Prevention of Cataracts Follow-up Study|
- Cataract surgery [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model
- Risk factors for cataract surgery [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model
- All-cause mortality [ Time Frame: 15 years post-intervention ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Antioxidant supplementation
Randomized to receive antioxidant supplementation (vitamin C, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 IU) three times per week for five years.
|Dietary Supplement: Antioxidant|
Placebo Comparator: Placebo
Randomized to receive placebo three times per week for five years
|Aravind Eye Hospitals|
|Madurai, Tamil Nadu, India|
|Principal Investigator:||Jeremy D Keenan, MD, MPH||University of California, San Francisco|
|Principal Investigator:||Muthiah Srinivasan, MD||Aravind Eye Hospitals|