Antioxidants for Prevention of Cataracts Follow-up Study

Cataract Clinical Trial

Official title:

Antioxidants for Prevention of Cataracts Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664819
• Other study ID #: P0047247
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• participation in previous cataract study

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Cataract

Intervention

Dietary Supplement:
• Antioxidant

• Placebo

Locations

Country	Name	City	State
India	Aravind Eye Hospitals	Madurai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Aravind Eye Hospitals, India

Country where clinical trial is conducted

India, 

References & Publications (1)

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. Epub 2006 Mar 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cataract surgery	Effect of intervention on cataract surgery 15 years post-intervention in a logistic regression model	15 years post-intervention
Secondary	Risk factors for cataract surgery	Association of risk factors assessed via questionnaire 15 years ago with cataract surgery in a multiple logistic regression model	15 years post-intervention
Secondary	All-cause mortality		15 years post-intervention