Nutritional Supplements and Performance During Visual Field Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in 24-2 visual field test
研究概览
简要总结
This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.
详细描述
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of primary open-angle glaucoma;
- •Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes;
- •Best corrected visual acuity better than 20/40 in both eyes;
- •Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).
排除标准
- •Significant cataract or media opacity;
- •Diagnosis of dementia, Alzheimer's, and other neurological diseases;
- •Current use or use in the past 1 month of nutritional supplements;
- •Inability to take or intolerance to nicotinamide and/or pyruvate.
研究组 & 干预措施
Placebo
This group will receive an equal number of tablets as the N&P group.
干预措施: Placebo (Dietary Supplement)
Nicotinamide and Pyruvate (N&P)
This group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate.
干预措施: Pyruvate (Dietary Supplement)
Nicotinamide and Pyruvate (N&P)
This group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate.
干预措施: Vitamin B3 (Dietary Supplement)
结局指标
主要结局
Change in 24-2 visual field test
时间窗: Up to 20 weeks
Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared.
次要结局
- Change in Montreal Cognitive Assessment (MoCA) scores(Up to 20 weeks)
研究者
Jeffrey Liebmann
Professor of Ophthalmology
Columbia University