Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
研究概览
简要总结
Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.
The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects
- •age between 20 and 80 years old
- •Well controled intra-ocular pressure under treatment (PIO<21mmHg or decreased by 20% compared to initial the PIO)
排除标准
- •retinal or macular disease
- •diagnosis of cataract or surgery of cataract during the follow-up
- •allergy to citicolin
- •ocular hypertonia due to a secondary cause (like corticosteroids)
- •history of anterior, intermediate or posterior uveitis
- •general treatment affecting PIO (beta blockers, corticosteroids)
- •pregnancy or breastfeeding
研究组 & 干预措施
MEMOPTIC added to the usual treatment of glaucoma
MEMOPTIC added to the usual treatment of glaucoma
干预措施: MEMOPTIC (Drug)
usual treatment of glaucoma
usual treatment of glaucoma
干预措施: usual treatment of glaucoma (Drug)
结局指标
主要结局
Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment
时间窗: from day 0 to 2 years
Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment versus visual field of open angle-glaucoma patients without MEMOPTIC treatment. Visual field is measure with METROVISION Visual Field 24-2, a full field projection perimeter entirely compatible with the Goldmann standard and modern perimetry standard. It allows high resolution static perimetry as well as kinetic perimetry with automated and manual modes. Automated static perimetry is one of the methods used to screen and follow up patients who have glaucoma. It consists of approximately 100 quantitative threshold measures that permit evaluation of retinal sensitivity. Each measure is standardized in a population free of ocular disease, and two simple statistics are calculated: mean deviation (MD) and pattern standard deviation (PSD). These indices are widely used in glaucoma clinical trials and patient follow-up.
次要结局
未报告次要终点