Cataract
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAntioxidant
DIETARY_SUPPLEMENTPlacebo
Sponsors
Aravind Eye Hospitals, India
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* participation in previous cataract study
Exclusion criteria
* refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cataract surgery | 15 years post-intervention | Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors for cataract surgery | 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 | 15 years post-intervention | — |
Countries
India
Outcome results
None listed