Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of Ganglionar cells complex (GCC)
研究概览
简要总结
To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
详细描述
AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of POAG
- •aged between 18 and 75 years
- •Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
- •myopia less than 5 diopters (D) were considered eligible for inclusion.
排除标准
- •IOP levels exceeding 21 mmHg,
- •hyper-sensitivity to citicoline,
- •a history of optic neuritis,
- •previous glaucoma or retinal surgery,
- •prior cataract or refractive surgery,
- •macular degeneration or other retinal disorders,
- •any systemic diseases that could potentially lead to neurodegeneration (e.g., multiple sclerosis, diabetes)
结局指标
主要结局
Evaluation of Ganglionar cells complex (GCC)
时间窗: From enrollment to the end of treatment at 1 year
evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) on GCC using optical coherence tomography (OCT)
次要结局
- Evaluation of Retinal nerve fiber layer (RNFL)(From enrollment to the end of treatment at 1 year)
研究者
Luca D'Andrea
Prinicipal investigator
University of Naples