Antioxidants for Prevention of Cataracts Follow-up Study

University of California San Francisco (UCSF)

Status: Completed

Conditions: Cataract

Treatments: Dietary Supplement: Antioxidant; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01664819

P0047247

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participation in previous cataract study

Exclusion criteria

• refusal to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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576 participants in 2 patient groups, including a placebo group

Antioxidant supplementation

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Antioxidant

Placebo

Placebo Comparator group

Description:

Randomized to receive placebo three times per week for five years

Treatment:

Dietary Supplement: Placebo