Status:
NOT_YET_RECRUITING
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches
Lead Sponsor:
University of California, San Francisco
Conditions:
Optic Nerve Injuries
Sellar Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- Patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.
- Must not present with any permanent or temporal visual deficit.
- Must receive an open or endoscopic endonasal procedure as part of their care.
Exclusion
- Preexisting visual impairments unrelated to the tumor.
- History of prior cranial surgeries or radiation therapy.
- Significant cognitive impairment or inability to provide informed consent
- Contraindications to microstimulation procedures such as uncontrolled coagulopathy or active infection.
- Patients with tumors located outside the sellar region or those requiring emergent or urgent surgery due to life-threatening complications.
- Additionally, individuals with systemic conditions or comorbidities that may significantly impact visual function or surgical outcomes, such as uncontrolled diabetes mellitus or severe cardiovascular disease.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06495580
Start Date
August 1 2024
End Date
December 1 2026
Last Update
July 12 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143