a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Macular Layer Thickness
研究概览
简要总结
Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.
As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.
There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.
The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
participant , investigator
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
- •willing to receive a steroidal regimen
- •no pathologic finding in first oct
- •no pathology and history of optic neuritis in contralateral eye
- •<14 days since onset visual loss
排除标准
- •Contraindication or known allergy to Phenytoin
- •Use of a calcium channel or sodium channel blocker in the past 2 months
- •Corticosteroid use in the past 2 months
- •Pregnancy
- •Significant cardiac, renal or liver abnormalities
- •Prior clinical episode of optic neuritis in either eye
- •Bilateral acute optic neuritis
- •Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
- •Refractive error of greater than +5 or -5 diopters
- •Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
研究组 & 干预措施
phenytoin
patients received phenytoin 100mg three time daily up to 3 months
干预措施: Phenytoin (Drug)
placebo
patients received placebo 100 mg three time daily for 3 months
干预措施: placebo (Drug)
结局指标
主要结局
Macular Layer Thickness
时间窗: Measured at baseline and month 1, 6
macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
Visual Field Mean Deviation in Decibel
时间窗: Measured at baseline and month 6
The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
Retinal Ganglion Cell Inner Plexiform Layer Thickness
时间窗: Measured at baseline and month 1, 6
ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Best Corrected Visual Acuity
时间窗: at baseline and month 6
Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
次要结局
- Retinal Nerve Fibre Layer Thickness in Micrometer(Measured at baseline and month1 ,6)