Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,020
- 试验地点
- 2
- 主要终点
- Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
研究概览
简要总结
The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in preventing age-related cataract or delaying its progression in participants with early or no cataract at baseline.
详细描述
Despite dramatic increase in the rates of cataract surgery during the last decades, age-related cataract is still responsible for about 50% of cases of severe visual impairment in developing countries, and for high and growing health care costs in western countries. CTNS was designed to complement the U.S. Age-Related Eye Disease Study (AREDS) by evaluating a much broader spectrum of nutrients at RDA dosages. Whereas about 60% of the AREDS control group was taking RDA dose multivitamin supplements, none of the participants in CTNS had taken any type of nutritional supplement for at least one year before the qualification visit. Therefore, the CTNS will be able to evaluate the effect of RDA doses versus no supplementation at all. CTNS and AREDS will use similar procedures, including those for grading the presence and severity of lens changes.
CTNS is a randomized,parallel group, placebo controlled, double blinded, single center, intervention trial.
Primary Outcomes: photographic evaluation of a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract surgery.
Secondary Outcomes: increase in type-specific opacity grade, cataract surgery, and visual acuity loss from baseline > or = 15 letters.
Patients will be followed for a maximum of 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical and photographic diagnosis of early or no age-related cataract
- •Participants with early cataract must have at least one eligible eye with VA score 20/32 or better
- •Participants with no cataract must have VA score 20/32 or better in both eyes.
排除标准
- •Advanced cataract
- •Bilateral aphakia or pseudophakia
- •Any ocular disease or condition that might complicate the future evaluation of cataract
- •Regular use of nutritional supplements
- •Failure to take at least 75% of run-in medication
- •Cancer with evidence of recurrence in the past 5 years
- •Major cerebral or cardiovascular events in past 12 months
- •Current participation to other clinical trials
- •Any condition likely to prevent adherence to CTNS follow-up schedule
结局指标
主要结局
Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up
时间窗: at yearly intervals from baseline for approximately ten years
number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.
次要结局
- Number of Participants Showing Development or Progression of Nuclear Lens Opacities(at yearly intervals from baseline for approximately ten years)
- Number of Participants Showing Development or Progression of Cortical Lens Opacities(at yearly intervals from baseline for approximately ten years)
- Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities(at yearly intervals from baseline for approximately ten years)
- Number of Participants Undergoing Cataract Surgery(at 6 month intervals from baseline for approximately 10 yrs)
- Number of Participants With a Decrease in Visual Acuity(at 6 month intervals from baseline for approximately 10 yrs)