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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Surgery
Optic Nerve and Pathway Injury

Treatments

Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®

Study type

Interventional

Funder types

Other

Identifiers

NCT01517789
CHUBX 2011/09

Details and patient eligibility

About

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.

Full description

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).

Enrollment

40 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with lesion compressing or near the optical pathways

Exclusion criteria

  • Patients with photic epilepsy

Trial design

40 participants in 1 patient group

Patients
Experimental group
Treatment:
Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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