Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Conditions
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Surgery, Optic Nerve and Pathway Injury

Intervention / Treatment
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* Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with lesion compressing or near the optical pathways Exclusion Criteria: Patients with photic epilepsy

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br> | Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®<br>* Visual assessment (visual field, visual acuity, pattern visual evoked potential) are realised before and after surgery. Flash and steady state visual evoked potential are measured during the surgical procedure at different times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of visual function six months after surgery. | Visual function : visual field and visual acuity six months after surgery. | Month 6 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Optic Nerve and Pathway Injury, visual event-related potential