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Completed

NCT Number: NCT01664819

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aravind Eye Hospitals

Madurai, Tamil Nadu, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participation in previous cataract study

Exclusion criteria

  • refusal to participate

Treatment and study plan

Antioxidant

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Cataract surgery

    Time frame: 15 years post-intervention

    Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model

Secondary outcomes

  1. 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

  2. All-cause mortality

    Time frame: 15 years post-intervention

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Aravind Eye Hospitals, India

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2012
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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