Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study
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
- Citicoline and metabolites concentration in human vitreous
研究概览
简要总结
Elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. The vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.
详细描述
At the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy.
Additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (CCT) and corneal endothelial cells density (ECD) evaluations.
Patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery.
Five patients served as controls and received a vehicle solution without citicoline.
The primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •ability to understand and sign the written informed consent
- •diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy
排除标准
- •laser treatments and ocular surgery in the past 6 months
- •hypersensitivity to the active ingredients used in the study
- •other systemic or ocular diseases different from ERM that could affect the outcome of the study
- •aphakia or previous complicated cataract surgery
- •intraocular lens (IOL) in the anterior chamber
- •treatment with systemic citicoline or other potential neuroprotective agents in the past 6 months
- •pregnancy or breastfeeding
研究组 & 干预措施
Citicoline eyes
Patients had to administer 3 drops/day of an ophthalmic solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride for 14 days before surgery and 2 hours prior to surgery.
干预措施: Citicoline (Drug)
结局指标
主要结局
Citicoline and metabolites concentration in human vitreous
时间窗: 14 days
Evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration.
次要结局
- Citicoline and metabolites concentration in phakic and pseudophakic eyes(14 days)