ISRCTN71306406已完成不适用
Prospective, open, pilot study of oral supplementation with lutein in patients having undergone cataract surgery: effect on macular pigment density
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)0 个研究点目标入组 40 人开始时间: 2009年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men or women aged over 55 years
- •2. Having to undergo cataract surgery on one eye (study eye) with extracapsular cataract extraction (ECCE) by phacoemulsification and insertion of a posterior chamber implant
- •3. Written informed consent
排除标准
- •1. Body mass index (BMI) greater than or equal to 29 kg/m^2
- •2. Poor pupillary dilation less than 6 mm with mydriatic drugs
- •3. Age-related maculopathy or macular degeneration (Age-Related Eye Disease Study [AREDS] class 2, 3 or 4)
- •4. Diabetic retinopathy
- •5. History of other progressive disease in the study eye which may complicate the assessment of pigment density
- •6. Known sensitivity to lutein, vitamin E or vehicules
- •7. Use of cholesterol-lowering drugs that act as bile acid binders (may interfere with carotenoid absorption) within the last month
- •8. Concomitant disease or therapy which could interfere with lutein absorption
- •9. Supplementation with carotenoids within the previous 6 months
- •10. Drastic change of food and/or food supplements within the last month
- •11. Involvement in the last 30 days in any investigational drug study
研究者
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