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临床试验/NCT01664819
NCT01664819已完成不适用

Antioxidants for Prevention of Cataracts Follow-up Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 576 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
576
试验地点
1
主要终点
Cataract surgery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participation in previous cataract study

排除标准

  • refusal to participate

结局指标

主要结局

Cataract surgery

时间窗: 15 years post-intervention

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

次要结局

  • All-cause mortality(15 years post-intervention)
  • Risk factors for cataract surgery(15 years post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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