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

NCT01517789 | Completed

• 2 other identifiers: CHUBX 2011/092011-A01220-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Optic Nerve and Pathway Injury

Keywords

Surgery; Optic Nerve and Pathway Injury; visual event-related potential

Outcome Measures

Primary Outcomes (1)

• Evolution of visual function six months after surgery.

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

  Month 6 after surgery

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

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.

Patients

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lesion compressing or near the optical pathways

You may not qualify if:

• Patients with photic epilepsy

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux - hôpital Pellegrin

Bordeaux, 33000, France

Location

Study Officials

• Daniel LAGUERRE, Dr

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Paul PEREZ, Dr

  University Hospital, Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 1, 2026

Record last verified: 2015-03

Locations

FR (1)