Antioxidants for Prevention of Cataracts Follow-up Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Aravind Eye Hospitals, India
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01664819
First received: August 10, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Cataract
Dietary Supplement: Antioxidant

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 798
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participation in previous cataract study

Exclusion Criteria:

  • refusal to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664819

Locations
India
Aravind Eye Hospitals
Madurai, Tamil Nadu, India
Sponsors and Collaborators
University of California, San Francisco
Aravind Eye Hospitals, India
Investigators
Principal Investigator: Jeremy D Keenan, MD, MPH University of California, San Francisco
Principal Investigator: Muthiah Srinivasan, MD Aravind Eye Hospitals
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01664819     History of Changes
Other Study ID Numbers: P0047247
Study First Received: August 10, 2012
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014