ChiCTR1900021998进行中（未招募）不适用
神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗
Health and Medical Research Fund 20173 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年4月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Comparing the rates of RNFL thinning measured with a swept-source OCT over 24 months of follow-up between the treatment arms
研究概览
简要总结
The study will randomize 125 patients with primary open-angle glaucoma (POAG) to receive an oral supplement of nicotinamide riboside 300 mg/day or a placebo (corn starch capsules) with an objective of comparing the rates of RNFL thinning (primary outcome measure) measured with a swept-source OCT over 24 months of follow-up between the treatment arms.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Both the investigators and the patients will be blinded for the treatment assignment.
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Age >=18 years; best corrected VA >=20/40; IOP <= 28mmHg; no history of laser procedure or intraocular surgery other than uncomplicated cataract extraction; patients with evidence of progressive RNFL/GCIPL thinning detected by Guided Progression Analysis(GPA) or Trend-based Progression Analysis (TPA)
排除标准
- •Pathological myopia; diseases that may cause visual field loss or optic disc abnormalities other than glaucoma; inability to perform reliable visual field; suboptimal quality of OCT images; and diabetic retinopathy/maculopathy; and a history of abnormal liver function.
研究组 & 干预措施
Group 1
Nicotinamide riboside 300mg/day
Group 2
Placebo
结局指标
主要结局
Comparing the rates of RNFL thinning measured with a swept-source OCT over 24 months of follow-up between the treatment arms
时间窗: 24 months
次要结局
- Time to visual field progression(Over 24 months)
- Time to progressive RNFL/GCIPL thinning(Over 24 months)
- The rates of change of visual field mean deviation and visual sensitivity at individual visual field locations(Over 24 months)
- Changes in visual field mean deviation (MD) and visual sensitivity at individual locations(1 month)
研究者
研究点 (3)
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