Antioxidants for Prevention of Cataracts Follow-up Study

NCT ID: NCT01664819

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antioxidant

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Randomized to receive placebo three times per week for five years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Antioxidant

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• participation in previous cataract study

Exclusion Criteria

• refusal to participate

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aravind Eye Hospitals, India

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy D Keenan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Muthiah Srinivasan, MD

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospitals

Locations

Aravind Eye Hospitals

Madurai, Tamil Nadu, India

Countries

India

References

Gritz DC, Srinivasan M, Smith SD, Kim U, Lietman TM, Wilkins JH, Priyadharshini B, John RK, Aravind S, Prajna NV, Duraisami Thulasiraj R, Whitcher JP. The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India. Br J Ophthalmol. 2006 Jul;90(7):847-51. doi: 10.1136/bjo.2005.088104. Epub 2006 Mar 23.

Reference Type: BACKGROUND

PMID: 16556618 (View on PubMed)

Nesemann JM, Srinivasan M, Ravindran RD, Edwards T, O'Brien KS, Kim UR, Wilkins JH, Whitcher JP, Lietman TM, Gritz DC, Keenan JD. Relationship Between Cooking Fuel and Lens Opacities in South India: A 15-Year Prospective Cohort Study. Am J Ophthalmol. 2022 Nov;243:66-76. doi: 10.1016/j.ajo.2022.06.021. Epub 2022 Jul 9.

Reference Type: DERIVED

PMID: 35817091 (View on PubMed)

Other Identifiers

P0047247

Identifier Type: -

Identifier Source: org_study_id