NCT02379169Unknown不适用
Effects of Sea Buckthorn Oil and Lutein on Eye Health
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Change in macular pigment optical density from baseline to 6 mo
研究概览
简要总结
Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •macular pigment optical density equal to or less than 0,40 OD
排除标准
- •diabetic retinopathy
- •macular changes associated with high blood pressure
- •signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74)
- •severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract
结局指标
主要结局
Change in macular pigment optical density from baseline to 6 mo
时间窗: 0 mo, 3 mo, 6 mo
measurement of macular pigment optical density
次要结局
- Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo(0 months, 6 months)
- Change in symptoms of dry eye from baseline to 6 mo(0 months, 3 months, 6 months)
- Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo(0 months, 6 months)
- Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo(0 months, 6 months)
- Change in contrast sensitivity from baseline to 6 mo(0 mo, 3 mo, 6 mo)
- Change in vision aquity from baseline to 6 mo(0 mo, 3 mo, 6 mo)
- Change in vision functioning from baseline to 6 mo(0 mo, 3 mo, 6 mo)
- Change in tear film osmolarity from baseline to 6 mo(0 mo, 3 mo, 6 mo)
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