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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01517789
First received: January 20, 2012
Last updated: May 9, 2014
Last verified: May 2014

January 20, 2012
May 9, 2014
January 2012
July 2014   (final data collection date for primary outcome measure)
Evolution of visual function six months after surgery. [ Time Frame: Month 6 after surgery ] [ Designated as safety issue: No ]
Visual function : visual field and visual acuity six months after surgery.
Same as current
Complete list of historical versions of study NCT01517789 on ClinicalTrials.gov Archive Site
  • Score of the visual field. [ Time Frame: Month 6 after surgery ] [ Designated as safety issue: No ]
  • Score of visual acuity [ Time Frame: Month 6 after surgery ] [ Designated as safety issue: No ]
  • Average diameter of the optic nerve fibers measured with Optical coherence tomography [ Time Frame: Month 6 after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways
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.

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).
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Surgery
  • Optic Nerve and Pathway Injury
Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®

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.

Experimental: Patients
Intervention: Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with lesion compressing or near the optical pathways

Exclusion Criteria:

  • Patients with photic epilepsy
Both
13 Years and older
No
Contact: Daniel LAGUERRE, Dr daniel.laguerre@chu-bordeaux.fr
France
 
NCT01517789
CHUBX 2011/09
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Daniel LAGUERRE, Dr University Hospital, Bordeaux, France
Study Chair: Paul PEREZ, Dr University Hospital, Bordeaux, France
University Hospital, Bordeaux
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP