Antioxidants for Prevention of Cataracts Follow-up Study

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Dietary Supplement: Antioxidant; Dietary Supplement: Placebo

• Registration Number: NCT01664819
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

• participation in previous cataract study

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Exclusion Criteria

• refusal to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antioxidant supplementation	Antioxidant	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.
Placebo	Placebo	Randomized to receive placebo three times per week for five years

Primary Outcome Measures

Name	Time	Method
Cataract surgery	15 years post-intervention	Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	15 years post-intervention
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

Trial Locations

Locations (1)

Aravind Eye Hospitals; 🇮🇳 Madurai, Tamil Nadu, India