Recruiting

Visual Evoked Potentials

Sponsor:

Fahad AlKherayf

Code:

NCT04068220

Conditions

Chiasmal; Lesion

Prechiasmal; Lesion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

intraoperative FVEPs monitoring

Study Details

Brief summary:

Skull base surgeries performed in areas involving the visual pathway are associated with varying levels of postoperative visual dysfunction. The goal of intraoperative FVEP monitoring is to detect and prevent intraoperative visual pathway injury.

Conditions

Chiasmal; Lesion

Prechiasmal; Lesion

Study ID

NCT04068220

Start date

Mar 2, 2020

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult population (18 years and older), admitted to The Ottawa Hospital (TOH)-Civic Campus for a chiasmal or pre-chiasmal lesion, undergoing first time minimally invasive endoscopic skull base surgery
  • Patient able to personally sign and date the informed consent document
  • Patients will be selected based on the surgeon's determination that:

1. The visual system will be at risk of iatrogenic injury
2. The intraoperative FVEPs monitoring could rapidly detect this injury AND
3. Corrective measures could be taken during surgery to reverse it.

Exclusion Criteria:

  • patients having a pre-existent retinal disease, cardiac pacemaker
  • contraindication for total intravenous anaesthesia (TIVA)
  • unable to complete required pre and post-operative visual assessment or unable to complete their post-operative follow-up visits at TOH-Civic Campus
  • anticipated goggle movement related to reflection of the frontal skin flap
  • preoperative visual deficits (e.g., profound deficits in visual acuity or dense visual field loss)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Intraoperative FVEPs monitoring

adult patients admitted to TOH - Civic Campus, for chiasmal or pre-chiasmal lesions undergoing a first time minimally invasive endoscopic skull base surgery.

Interventions

intraoperative FVEPs monitoring

During the surgery, a pair of goggles (similar to the swimming goggles) will be placed on patient's closed eyes. The goggles equipped with red LEDs will apply no pressure or minimal pressure on patient's closed eyes. Patient's left eye then right eye will be stimulated with flashing red light emitted by the goggles. Two subdermal needle electrodes will be placed under the skin behind patient's ears, and one subdermal needle electrode will be placed under the skin above the bridge of patient's nose. The two electrodes placed behind patient's ears, will record intraoperative flash visual evoked potentials (FVEPs) resulted from red light stimulation of patient's visual pathway through the eyes and the electrode above the bridge of the nose will record, at the same time, the activity of each eye's retina.

Primary outcome measure

  • Examine the feasibility of detecting iatrogenic visual pathway injury by using intraoperative monitoring of continuous FVEPs in minimally invasive endoscopic skull base surgery. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ioana D Moldovan, MD MSc

613-798-5555imoldovan@ohri.ca

Locations

The Ottawa Hospital - Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Ioana D Moldovan, MD MSc

613-798-5555imoldovan@ohri.ca

Principal Investigator:

Fahad Alkherayf, MD MSc FRCSC

More Information

Sponsor

Fahad AlKherayf

Last update posted

Sep 18, 2020

Last verified

Sep, 2020

Keywords

  • chiasmal, prechiasmal, lesion, endoscopic skull base surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fahad AlKherayf on 2020-09-18.