Status:
UNKNOWN
Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Endoscopic Skull Base Surgery
Lead Sponsor:
Fahad AlKherayf
Collaborating Sponsors:
Ottawa Hospital Research Institute
Conditions:
Chiasmal; Lesion
Prechiasmal; Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Skull base surgeries performed in areas involving the visual pathway are associated with varying levels of postoperative visual dysfunction. For instance, surgical resection of suprasellar meningiomas...
Eligibility Criteria
Inclusion
- 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:
- The visual system will be at risk of iatrogenic injury
- The intraoperative FVEPs monitoring could rapidly detect this injury AND
- Corrective measures could be taken during surgery to reverse it.
Exclusion
- 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)
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04068220
Start Date
March 2 2020
End Date
December 31 2021
Last Update
September 18 2020
Active Locations (1)
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1
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9