European Nutrition in Glaucoma Management Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in MPOD in response to treatment from baseline at 18 months
研究概览
简要总结
European Nutrition in Glaucoma Management (ENIGMA) trial will evaluate the effect of 18-month supplementation with lutein, zeaxanthin and meso-zeaxanthin on macular pigment (MP) levels, vision, cognition and serum biomarkers of inflammation and oxidative stress in glaucoma patients.
This study comprises a randomised, placebo controlled and double masked clinical trial designed to establish MP response to supplementation with lutein, zeaxanthin and meso-zeaxanthin over an 18-month period. The study will also investigate the relationship between macular pigment, cognitive function, oxidative stress and inflammation, and determine the impact of dietary supplementation on vision, retinal structure, quality of life and cognitive function among glaucoma subjects.
详细描述
This is a research study looking at the effects of dietary MP supplementation in glaucoma patients. Glaucoma can cause irreversible visual impairment. Current treatment modalities only halt disease progression and do not improve visual function. It is important to understand that poor visual function can have major consequences to an individual's day-to-day tasks such as increased risk of falls and automobile accidents.
Disability glare is commonly experienced by eye disease patients, including those with glaucoma, and has been shown to be present even in those who are mildly affected by the disease. MP is a blue-light filter that plays an important role in visual performance including glare sensitivity. Moreover, MP is a potent antioxidant, and it is widely known that oxidative stress is involved in the pathogenesis of glaucoma, both at the level of retinal ganglion cells and trabecular meshwork.
Glaucoma and cognitive decline are both neurodegenerative processes that share several antecedents. The clustering of degenerative disorders towards the end of life is thought to be the result of cumulative and lifelong oxidative injury, and is consistent with the free radical theory of aging. Observational studies have revealed links between the two conditions. The commonalities between glaucoma and cognitive decline, including their shared risk factor profile and pathophysiological pathways, suggest a role for exploring common mechanisms and perhaps even a shared therapeutic approach.
The purpose of this study is to investigate the effects of dietary MP supplementation on MP levels, serum biomarkers of inflammation and oxidative stress, vision, retinal structure and cognition in glaucoma patients.
Study design 64 glaucoma participants Treatment arm: 10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin - 2/3 Placebo arm: Identical capsule containing no active ingredients - 1/3 Duration of intervention: 18 months
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open-angle glaucoma patients aged 18 years or older
- •Primary open-angle glaucoma (POAG)
- •Normal-tension glaucoma (NTG)
- •Pseudoexfoliative glaucoma
- •Pigment dispersion glaucoma
- •Best corrected visual acuity of better than 6/12 in the study eye (logMAR <0.3)
- •Either gender
- •Able to give informed consent, make the required study follow-up visits and adhere to trial protocol
排除标准
- •Underlying ocular disease such as age-related macular degeneration, diabetic retinopathy or moderate to significant cataract (patients with established cataract who are likely to progress)
- •Best corrected visual acuity of worse than 6/12 in the study eye (logMAR > 0.3)
- •History of diabetes mellitus, any type of dementia (e.g. Alzheimer's has been shown to be associated with lower macular pigment levels) or other significant systemic condition that might affect capacity to complete the trial
- •MMSE score < 26
- •Individuals taking dietary macular pigment supplements (containing lutein, zeaxanthin and meso-zeaxanthin, such as MacuShield, Ocuvite Lutein/Complete, I-Caps etc.) in the past 6 months
研究组 & 干预措施
Active
Softgel capsules: 10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin once a day with a meal for 18 months
干预措施: 10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin (Dietary Supplement)
Placebo
Identical capsule containing no active ingredients
干预措施: Placebo (Other)
结局指标
主要结局
Change in MPOD in response to treatment from baseline at 18 months
时间窗: 18 months
Change in MPOD measured at each study visit from baseline to 18 months will be evaluated between active and placebo arms
次要结局
- Change in Contrast Sensitivity in response to treatment from baseline at 18 months(18 months)
- Change in serum biomarkers of oxidative stress (Oxidized LDL) from baseline following 18 months supplementation(18 months)
- Change in verbal fluency (FAS score) from baseline following 18 months supplementation(18 months)
- Change in incremental light sensitivity in response to treatment from baseline at 18 months(18 months)
- Change in multisensory integration from baseline following 18 months supplementation(18 months)
- Change in flanker task scores (reaction time and attention) from baseline following 18 months supplementation(18 months)
- Change in verbal fluency (animal fluency test) from baseline following 18 months supplementation(18 months)
- Change in Visual Acuity in response to treatment from baseline at 18 months(18 months)
- Change in serum biomarkers of inflammation (C-reactive protein) from baseline following 18 months supplementation(18 months)
- Change in SKT (Syndrom-Kurztest) score from baseline following 18 months supplementation(18 months)
- Change in Retinal Thickness parameters in response to treatment from baseline at 18 months(18 months)