Effects of Lutein Supplementation on Macular Pigment Optical Density and Visual Acuity in Patients With Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Macular pigment optical density (MPOD) as measured with optical reflectometry
研究概览
简要总结
The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that this absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina.
Age-related macular degeneration is the leading cause of blindness among developed countries. The pathogenesis of this disease remains unknown. There is, however, evidence that low fruit and vegetable consumption increases the risk of Age-Related Macular Degeneration (AMD). Accordingly, it has been hypothesized that lutein supplementation may be beneficial in AMD. The present study investigates whether 6 months lutein supplementation increases MP optical density (OD), influences visual acuity, depth and dimension of central scotoma and alters symptoms in patients with AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nonexudative AMD (either categories 2, 3 or 4 according to the AREDS criteria; in group 4 the eyes with no-advanced AMD will be included, Age-Related Eye Disease Study Research Group 2001)
- •Age between 50 and 90 years
- •Clear non-lenticular ocular media
- •Visual acuity > 0.4
排除标准
- •Primary retinal pigment epithelium atrophy > 125 µm
- •Moderate or severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Previous treatment with lutein within 3 month of study initiation
- •History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- •Ocular surgery within the last 6 months
- •Treatment with photosensitizing drugs
结局指标
主要结局
Macular pigment optical density (MPOD) as measured with optical reflectometry
时间窗: 5 minutes
次要结局
- Determination of an increased systemic antioxidative state in plasma and low density lipoprotein and Plasma lutein concentrations(5 minutes)
- Changes in fundus appearance as documented with fundus photos(5 minutes)
- Visual acuity using ETDRS charts(15 minutes)
- Central visual field defects assessed with scanning laser scotometry(30 minutes)
研究者
Gerhard Garhofer
Assoc. Prof. Priv.-Doz.
Medical University of Vienna