S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13,475
- 试验地点
- 1
- 主要终点
- Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
研究概览
简要总结
RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer.
PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).
详细描述
OBJECTIVES:
Primary
- To test whether vitamin E and/or selenium reduces the risk of visually significant age-related macular degeneration (AMD) in men enrolled on SELECT (SWOG-S0000).
- To test whether vitamin E and/or selenium reduces the risk of cataract in these participants.
Secondary
- To test whether vitamin E and/or selenium reduces the risk of advanced AMD in these participants.
- To test whether vitamin E and/or selenium reduces the risk of cataract surgery and subtypes in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
干预措施: vitamin E (Drug)
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
干预措施: selenium placebo (Drug)
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
干预措施: selenium (Drug)
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
干预措施: vitamin E placebo (Drug)
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
干预措施: selenium placebo (Drug)
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
干预措施: selenium (Drug)
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
干预措施: vitamin E (Drug)
Vitamin E placebo + selenium placebo
vitamin E placebo and selenium placebo daily for 7-12 years
干预措施: vitamin E placebo (Drug)
Vitamin E placebo + selenium placebo
vitamin E placebo and selenium placebo daily for 7-12 years
干预措施: selenium placebo (Drug)
结局指标
主要结局
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
时间窗: Every 6 months, up to 7 years
Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.
Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)
时间窗: Every 6 months, up to 7 years
Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)
次要结局
- Number of Participants With Advanced AMD(Every 6 months, up to 7 years)
- Number of Participants Who Underwent Cataract Extraction(Every 6 months, up to 7 years)