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Completed

NCT Number: NCT01517789

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

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux - hôpital Pellegrin

Bordeaux, 33000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with lesion compressing or near the optical pathways

Exclusion criteria

  • Patients with photic epilepsy

Treatment and study plan

Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®

Device

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.

Primary outcomes

  1. Evolution of visual function six months after surgery.

    Time frame: Month 6 after surgery

    Visual function : visual field and visual acuity six months after surgery.

Secondary outcomes

  1. Score of the visual field.

    Time frame: Month 6 after surgery

  2. Score of visual acuity

    Time frame: Month 6 after surgery

  3. Average diameter of the optic nerve fibers measured with Optical coherence tomography

    Time frame: Month 6 after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: VISUOPEV

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2012
Registry last updated
Jun 1, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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