University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT06495580
Assessing the function of the optic nerve is paramount during various neurosurgical procedures. Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. Here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. During surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. Electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Our hypothesis is that utilizing anterograde optic nerve microstimulation during open and endoscopic cranial approaches will allow for more accurate and real-time assessment of optic nerve function compared to the current standard of Visual Evoked Potentials. The investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes.
The study design proposed is interventional and prospective. It involves implementing a novel approach, anterograde optic nerve microstimulation, during surgical procedures to assess optic nerve integrity. This design entails actively intervening during the surgical process to stimulate the optic nerve and record responses, indicating an interventional approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anterograde Stimulation of the Optic Neve.
Time frame: 6 weeks after surgery date.
Patients that received our intervention will be evaluated post operatively for regular standard of care six weeks post-operatively. During visual evaluation, the PI of this study will determine post-operative visual field and visual acuity. These parameters will be compared to pre-operative visual acuity and visual field status.
Contact information is provided by the study sponsor or research team.
Daniel Quintana, BA
CONTACT
Ezequiel Goldschmidt, MD, PhD
CONTACT
University of California, San Francisco
Other
Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches
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