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
  Purpose

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.


Condition Intervention
Surgery
Optic Nerve and Pathway Injury
Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients 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.


Detailed 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).
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with lesion compressing or near the optical pathways

Exclusion Criteria:

  • Patients with photic epilepsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517789

Contacts
Contact: Daniel LAGUERRE, Dr daniel.laguerre@chu-bordeaux.fr

Locations
France
CHU Bordeaux - hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Daniel LAGUERRE, Dr       daniel.laguerre@chu-bordeaux.fr   
Contact: Marie LEGALL       marie.le-gall@chu-bordeaux.fr   
Principal Investigator: Daniel LAGUERRE, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Daniel LAGUERRE, Dr University Hospital, Bordeaux, France
Study Chair: Paul PEREZ, Dr University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01517789     History of Changes
Other Study ID Numbers: CHUBX 2011/09
Study First Received: January 20, 2012
Last Updated: May 9, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Surgery
Optic Nerve and Pathway Injury
visual event-related potential

Additional relevant MeSH terms:
Optic Nerve Injuries
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Eye Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014