Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Electrofunctional evaluation
研究概览
简要总结
Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.
详细描述
Prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution Kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression.
Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms:
- Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)
- Control group (CG): 10 patients will be evaluated as control
Once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. The following examinations will be done in the following sequence:
- Visual acuity
- Slit lamp evaluation
- PERG
- PEV pattern
- Tonometry
- Visual field
- Optical Coherence Tomography
- Dilated Fundus examination
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression
- •controlled intraocular pressure
- •at least 3 previous visual field examinations.
排除标准
- •angle closure glaucoma and secondary open angle glaucoma
- •refractive error outside +2D and -6D
- •ophthalmic surgery 6 months before the recruitment
- •presence of cataract or other conditions that could affect results of perimetry or electroretinography
- •treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months
- •presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.
结局指标
主要结局
Electrofunctional evaluation
时间窗: 3 months
Short term improvement in inner retinal function and bioelectrical activity of the visual cortex evaluated by means of PERG (P50 and N95 peaks) and PEV (P100 implicit time and N75-P100 amplitude) pattern.
次要结局
- VF and SD-OCT(3 months)