- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068220
Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Endoscopic Skull Base Surgery
Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Minimally Invasive Endoscopic Skull Base Surgery, a Novel Approach to Improve Patient Outcome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- Recruiting
- The Ottawa Hospital - Civic Campus
-
Principal Investigator:
- Fahad Alkherayf, MD MSc FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Evaluation of proportions (sensitivity and specificity) and performances (positive and negative predictive values)
|
1 year
|
Report the adverse events of intraoperative monitoring continuous FVEPs
Time Frame: 1 year
|
Determine the number and percentage of each identified adverse event of intraoperative continuous FVEPs monitoring.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fahad Alkherayf, MD MSc FRCSC, Ottawa Hospital Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20190533 - 01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chiasmal; Lesion
-
University of Sao PauloUnknownBand Atrophy | Chiasmal Compression | Neural LossBrazil
-
Lumenis Be Ltd.Not yet recruitingPigment; Lesion | Lesion; Vascular
-
Memorial Sloan Kettering Cancer CenterRecruitingSkin Lesion | Mucosal LesionUnited States
-
Fin-Ceramica Faenza SpaCompletedKnee Chondral Lesion | Knee Osteochondral LesionSwitzerland, Italy, Austria, Belgium, Germany, Norway, Poland, South Africa, Sweden
-
GuerbetBracco Imaging S.p.A.RecruitingCNS Lesion | Lesion in Body RegionJapan
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingCartilage Lesion | Osteochondral LesionFrance
-
Barmherzige Brüder EisenstadtUnknownDegenerative Lesion of Articular Cartilage of Knee | Osteochondral Lesion of Talus
-
BioGend Therapeutics Co.LtdCompletedChondral or Osteochondral Lesion of Medial Femoral Condyle | Chondral or Osteochondral Lesion of Lateral Femoral Condyle | Chondral or Osteochondral Lesion of TrochleaTaiwan
-
International Biomedical Systems S.p.A.Unknown
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
Clinical Trials on intraoperative FVEPs monitoring
-
Lütfiye Nuri Burat Government HospitalUnknown
-
Tianjin Medical University Cancer Institute and...Recruiting
-
Vilnius UniversityUnknownWound Heal | Percutaneous Transluminal Angioplasty | Ischemic FeetLithuania
-
ProPep Surgical, LLCIndiana University School of MedicineUnknownUrinary Incontinence | Erectile DysfunctionUnited States
-
University of ZurichEnrolling by invitationPatients Operated on at the Neurosurgery DepartmentSwitzerland
-
Alphatec Spine, Inc.RecruitingIntervertebral Disc Degeneration | Spondylolisthesis | Spinal Deformity | Stenosis, Spinal | Spinal InstabilityUnited States
-
University Hospital TuebingenCompletedBrain Tumor, Recurrent | Vestibular Schwannoma | Brainstem Glioma | Brainstem NeoplasmGermany
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalUnknown
-
Herlev and Gentofte HospitalCompletedUrinary Incontinence | Erectile Dysfunction | Male Urogenital Diseases | Prostatectomy | HumansDenmark
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingSpasticity, Muscle