Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- peripapillary RNFL thickness
研究概览
简要总结
since glaucoma is considered an optic neuropathy, new treatments for glaucoma are being continuously investigated, including neuroprotection.
Previous studies implied that phenytoin, a potent anti-convulsive drug, has a neuroprotective role, and Na+ channels blockage was suggested as a possible mechanism.
This study predicts that glaucoma patients taking Phenytoin will have a less advanced glaucoma as compared to patients not taking the drug. Glaucoma severity will be determined by visual acuity, visual fields, optic disc cupping and nerve fiber layer thickness
详细描述
The study will examine adult patients who suffer from glaucoma and epileptic disorders on the same time. the study group will include glaucoma patients, being treated with oral Phenytoin for their epileptic disorder. The study group will be compared to 2 control groups:
- Glaucoma patients with epileptic disorder,receiving different medication than Phenytoin
- Glaucoma patients with no epileptic disorder.
4 parameters will be evaluated for all groups:
- Best corrected visual acuity
- Optic disc cupping
- visual fields and general perimetric indices
- peripapillary retinal nerve fiber layer.
Every participant in the study,after giving his informed consent, will be evaluated by a senior ophthalmologist in a single office appointment. The appointment will include a visual acuity, complete ophthalmic examination,Humphrey perimetric visual field testing and peripapillary RNFL thickness measurement by OCT.
no drug or other treatment will be given to the participants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Clinical diagnosis of glaucoma
- •chronic treatment with phenytoin for any indication
排除标准
- •pregnancy
- •visual acuity less then 6/60
结局指标
主要结局
peripapillary RNFL thickness
时间窗: immediate
次要结局
- corrected pattern standard deviation in perimetric visual field(immediate)