Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Amplitude and Latency of Visual-Evoked Potential
研究概览
简要总结
The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary mechanism of injury. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. In this study, investigators aim to make a randomized controlled trial to certify the efficiency of optic nerve canal decompression for TON patients.
详细描述
surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the history of Traumatic Brain Injury or Craniofacial Trauma
- •Optic nerve compression（intraneural edema, nerve sheath hematoma or canal fracture with impingement)
- •Amplitude and latency abnormal or Ratio of amplitude of abnormal to normal side.
排除标准
- •Glasgow Coma Scale，Score<8
- •Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
- •Other Contraindications for surgery
研究组 & 干预措施
Optic nerve decompression
Optic canal and optic nerve sheath decompression within 5 days from trauma occur.
干预措施: Optic canal and optic nerve sheath decompression (Procedure)
methylprednisolone
a maximum daily dose of 1 g of methylprednisolone
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Amplitude and Latency of Visual-Evoked Potential
时间窗: from trauma day to 60 days after trauma
Name of Scale: Visual-Evoked Potential Physiological Parameter: Amplitude and Latency Questionnaire: Trauma day and 1 day, 2 days, 3 days, 7 days, 14 days, 30 days and 60 days after trauma. Two more test for the day before surgery（Medical） and the day after surgery(Medical). Measurement collection: Inpatient and outpatient
次要结局
- Vision level of Visual Acuity(from trauma day to 60 days after trauma)
研究者
Hou Lijun
Professor
Shanghai Changzheng Hospital