Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Surgery
- 发起方
- University Hospital, Bordeaux
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evolution of visual function six months after surgery.
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. There is no validated tool for intraoperative visual monitoring and few publications have studied this issue.
In a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. These parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (VEP). We suppose that these improvements will increase reliability of intraoperative VEP.
详细描述
This genuine optimised monitoring in France, set up in association with Metrovision company, should help increasing intraoperative VEP reliability as a monitoring tool for visual pathways function. In this study, we assess the predictive value of relevant intraoperative variations of VEP (more than 50% variation of latency and amplitude) on the visual prognosis at six months after surgery The visual assessment consisting of a visual field, a visual acuity, and the performance of pattern transient VEP, will be performed by an ophthalmologist before surgery, and at three and six months after surgery. An electroencephalogram with photostimulatory lighting will be used in pre-operative and will validate the absence of photo-induced epilepsy risk. During the intervention, VEPs associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by Metrovision company: * Under general anaesthesia, but before any surgery. * During the surgery, at predetermined surgical times (while performing the craniotomy or the sphenoid opening, at various times during the perioptic lesion dissection, after the lesion resection, when closing).
研究者
入排标准
入选标准
- •Patients with lesion compressing or near the optical pathways
排除标准
- •Patients with photic epilepsy
结局指标
主要结局
Evolution of visual function six months after surgery.
时间窗: Month 6 after surgery
Visual function : visual field and visual acuity six months after surgery.
次要结局
- Score of the visual field.(Month 6 after surgery)
- Score of visual acuity(Month 6 after surgery)
- Average diameter of the optic nerve fibers measured with Optical coherence tomography(Month 6 after surgery)