Chiasmal; LesionNCT04068220
Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Endoscopic Skull Base Surgery
A study testing intraoperative FVEPs monitoring in people with Chiasmal; Lesion and Prechiasmal; Lesion, run by Fahad AlKherayf at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chiasmal; Lesion, Prechiasmal; Lesion
- What is being tested?
- intraoperative FVEPs monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Ioana D Moldovan, MD MSc, 613-798-5555 ext. 18574, imoldovan@ohri.ca
Fahad Alkherayf, MD MSc FRCSC
About this study
Official title: Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Minimally Invasive Endoscopic Skull Base Surgery, a Novel Approach to Improve Patient Outcome
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.
Read the 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 has been shown to worsen visual function in 14 - 28% of patients and surgical resection of craniopharyngiomas worsen visual function in 3 - 11.5% of patients. Manipulation of the optic nerve and interference with the microvasculature during surgical dissection is thought to be responsible for the visual loss.
Through intraoperative monitoring and prompt identification of flash visual evoked potentials (FVEPs) deterioration, corrective surgical measures could be undertaken to improve or stabilize postoperative visual dysfunction. Furthermore, intraoperative FVEPs monitoring may influence surgical decision-making thus contributing to predict and prevent postoperative visual dysfunction as well as allowing more total resection of a tumour when the monitoring is stable.
This study's aim is to determine if intraoperative continuous FVEPs monitoring can predict and prevent or minimize possible visual pathway injury that may appear during minimally invasive endoscopic skull base surgery.
- Conditions
- Chiasmal; Lesion, Prechiasmal; Lesion
- Being tested
- intraoperative FVEPs monitoring
- Keywords
- chiasmal, prechiasmal, lesion, endoscopic skull base surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative FVEPs monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative FVEPs monitoring | Other | adult patients admitted to TOH - Civic Campus, for chiasmal or pre-chiasmal lesions undergoing a first time minimally invasive endoscopic skull base surgery. Receives: Other: intraoperative FVEPs monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the feasibility of detecting iatrogenic visual pathway injury by using intraoperative monitoring of continuous FVEPs in minimally invasive endoscopic skull base surgery.
This pilot study will evaluate the number of enrolled patients with stable and reliable FVEPs with ERGs, the number of enrolled patients with more than 50% decrease in intraoperative FVEPs N1-P1 amplitude (compared to baseline value) and the number of patients with permanent postoperative visual deficit. In addition, we will use demographic data for descriptive analysis, and obtain preliminary data for power analysis and information on subject recruitment before starting the large clinical trial.
Measured: 1 year
Secondary outcomes (2)
Determine sensitivity and specificity as well as positive and negative predictive value of intraoperative monitoring of continuous FVEPs in minimally invasive endoscopic skull base surgery.
Evaluation of proportions (sensitivity and specificity) and performances (positive and negative predictive values)
Measured: 1 year
Report the adverse events of intraoperative monitoring continuous FVEPs
Determine the number and percentage of each identified adverse event of intraoperative continuous FVEPs monitoring.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chiasmal; LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fahad AlKherayf
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Sponsor-investigator, Fahad AlKherayf, Ottawa Hospital Research Institute
- Investigators
- Fahad Alkherayf, MD MSc FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068220
- Sponsor's protocol ID
- 20190533 - 01H
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Minimally Invasive Endoscopic Skull Base Surgery, a Novel Approach to Improve Patient Outcome
- ClinicalTrials.gov ID
- NCT04068220
- Acronym / sponsor ID
- 20190533 - 01H
- Conditions
- Chiasmal; Lesion, Prechiasmal; Lesion
- Keywords
- chiasmal, prechiasmal, lesion, endoscopic skull base surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fahad AlKherayfUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 has been shown to worsen visual function in 14 - 28% of patients and surgical resection of craniopharyngiomas worsen visual function in 3 - 11.5% of patients. Manipulation of the optic nerve and interference with the microvasculature during surgical dissection is thought to be responsible for the visual loss.
Through intraoperative monitoring and prompt identification of flash visual evoked potentials (FVEPs) deterioration, corrective surgical measures could be undertaken to improve or stabilize postoperative visual dysfunction. Furthermore, intraoperative FVEPs monitoring may influence surgical decision-making thus contributing to predict and prevent postoperative visual dysfunction as well as allowing more total resection of a tumour when the monitoring is stable.
This study's aim is to determine if intraoperative continuous FVEPs monitoring can predict and prevent or minimize possible visual pathway injury that may appear during minimally invasive endoscopic skull base surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative FVEPs monitoring | Other | Other: intraoperative FVEPs monitoringadult patients admitted to TOH - Civic Campus, for chiasmal or pre-chiasmal lesions undergoing a first time minimally invasive endoscopic skull base surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative FVEPs monitoringDuring 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. | Other | Intraoperative FVEPs monitoring |
Primary outcome
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
This pilot study will evaluate the number of enrolled patients with stable and reliable FVEPs with ERGs, the number of enrolled patients with more than 50% decrease in intraoperative FVEPs N1-P1 amplitude (compared to baseline value) and the number of patients with permanent postoperative visual deficit. In addition, we will use demographic data for descriptive analysis, and obtain preliminary data for power analysis and information on subject recruitment before starting the large clinical trial.
2 secondary outcomes
Determine sensitivity and specificity as well as positive and negative predictive value of intraoperative monitoring of continuous FVEPs in minimally invasive endoscopic skull base surgery.
Time frame: 1 year
Report the adverse events of intraoperative monitoring continuous FVEPs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- The Ottawa Hospital websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahad Alkherayf, MD MSc FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative FVEPs monitoring in people with Chiasmal; Lesion and Prechiasmal; Lesion, run by Fahad AlKherayf at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioana D Moldovan, MD MSc (613-798-5555 ext. 18574, imoldovan@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.