ACTRN12622000414718招募中3 期
The Vitamin B3 in Glaucoma Study (VBIGS): A 2-year Multi-centre, Double-masked, Randomised, Placebo-controlled Trial of Nicotinamide (Vitamin B3) Supplementation in Glaucoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults with definitive, treated primary open angle glaucoma (POAG), normal tension glaucoma (NTG) or pseudoexfoliative glaucoma (PXFG) in both eyes
- •Best-corrected visual acuity of at least 6/18 in each eye
- •Severity of visual field (VF) loss, mean deviation (MD) between -3 and -18 dB. This range includes people with moderate disease which optimises detection of progression.
- •Patients must have prior 2-3 x 24-2 VF tests in the past which meet VF reliability criteria.
- •Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if more than 3 months prior, and normal liver function tests.
- •Those taking nicotinamide (NAM) already will undergo a 1-month washout period before commencing the study.
排除标准
- •Adults with a history of hepatic disease, visually significant cataracts, other conditions that can affect visual field results, glaucoma filtration surgery in last 6 months, cataract surgery in the last 3 months
研究者
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