The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- RVP effect
研究概览
简要总结
The impact of targeted vitamin supplementation on retinal venous pressure (RVP) and steady state pattern ERG (SSpERG) in patients with RVP 15mmHg or more above intra-ocular pressure (IOP) and serum homocystein 12µmol/l or more, with signs of progression in spite of adequate IOP control, as evidenced by SSpERG abnormality with or without structural progression or visual field progression,
详细描述
Provided the inclusion criteria were met, RVP measurement was repeated, and a 1 capsule/day regimen of Ocufolin® forte was subsequently carried out for a duration of 3 months, after which repeat measurements of IOP, SSpERG, and RVP were performed, along with dilated fundoscopy. .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •glaucoma and/or ocular vascular disease in at least on eye
- •abnormal SSpERG
- •RVP measured using an ophthalmodynamometer at least 15 mmHg higher than intra-ocular pressure (IOP),
- •fasting serum Hcy level > 12 µmol/l
- •stable and well-controlled IOP (with or without IOP-lowering treatment)
排除标准
- •starting other systemic or ocular medications with potential impacts on RVP within a month before entering the study or during the course of the study
- •starting or changing the dosage of other medications with potential impact on SSpERG within 3 months before entering the study or during the course of the study
- •non-adherence to the follow-up schedule
- •inability to perform a proper RVP measurement using ophthalmodynamometry.
结局指标
主要结局
RVP effect
时间窗: 3 months
measurement of RVP lowering effect
SSpERG effect
时间窗: 3 months
measurement of improvement of SSpERG
次要结局
未报告次要终点
研究者
Thibaut Devogelaere
Dr T Devogelaere, MD, FEBO
Devogelaere Vision