Antioxidants for Prevention of Cataracts Follow-up Study
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|ClinicalTrials.gov Identifier: NCT01664819|
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2012
Last Update Posted : June 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Dietary Supplement: Antioxidant Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||798 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Antioxidants for Prevention of Cataracts Follow-up Study|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||May 2018|
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
Dietary Supplement: Placebo
- Cataract surgery [ Time Frame: 15 years post-intervention ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664819
|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|