Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT04068220
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04068220
Study Brief:
Protocol Section:
NCT04068220