Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline Visual Capacity
研究概览
简要总结
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
详细描述
A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.
Enrollment: 50. Randomized groups (2)
- Standard treatment + placebo
- Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genres
- •Age between 18 and 85 years old.
- •Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)
- •1 month after symptoms started
- •If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included.
- •if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included.
排除标准
- •Visual field better than 20/60 at the beginning of the study.
- •History of optic neuritis in the eye under study.
- •History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study.
- •History of previous treatment with intravenous methylprednisolone since the onset of symptoms.
- •History of high myopia.
研究组 & 干预措施
Standard treatment + intervention
Intravenous Methylprednisolone succinate (1 g daily for 5 days) + retrobulbar injection of 2 cc (40 mg/mL) to methylprednisolone acetate
干预措施: Methylprednisolone Acetate 40 MG/ML [Depo-Medrol] (Drug)
结局指标
主要结局
Change from Baseline Visual Capacity
时间窗: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
次要结局
- Change from Baseline Color vision(Initial visit, 2-week visit, 1-month visit, 3-month visit)
- Change from Baseline Oct pRNFL (microns)(2-week visit, 3-month visit)
- Change from Baseline Visual field defect(Initial visit, 2-week visit, 1-month visit, 3-month visit)