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Optic Nerve Stimulation for Visual Deficits After Cranial Surgery

This study is testing a new way to monitor your optic nerve (the nerve that sends visual information from your eye to your brain) during brain surgery. It's for adults (18 and older) who have certain types of brain tumors, like meningiomas or pituitary adenomas, and are having surgery through the nose or an open approach. You must not have any existing vision problems. The study will use "Optic Nerve Stimulation" during surgery to see if it can give doctors a more accurate and real-time look at how your optic nerve is working, compared to current methods. The main goal is to see if this new monitoring method can help prevent vision problems after surgery, with vision checked 6 weeks after your operation. The study is currently recruiting about 20 participants.

Study design
This is an interventional study, meaning a new procedure (optic nerve stimulation) will be used during surgery. It is a prospective study, meaning participants are enrolled and followed forward in time.
What's involved
You would have pre- and post-operative visual evaluations. During surgery, your optic nerve and chiasm (where optic nerves cross) would be stimulated, and responses recorded.
Compensation
Not stated in the trial record.
Follow-up
Your visual deficits will be measured at 6 weeks after your surgery date.

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NCT06495580

Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Not Yet Recruiting
NAAges 18+InterventionalPrevention
University of California, San Francisco
~20 participants
Updated 2024-07-12 on ClinicalTrials.gov
What's tested:Optic Nerve Stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Deficits
Measured over 6 weeks after surgery date.

Conditions

Optic Nerve Injuries
Sellar Tumor
Skull Base Neoplasms

Explore related trials

Sellar Region NeoplasmSkull Base Neoplasm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ezequiel Goldschmidt, MD, PhD · PRINCIPAL_INVESTIGATOR · UCSF Department of Neurological Surgery

Who to contact

Ezequiel Goldschmidt, MD, PhD
[email protected]
415.514.6482
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Visual Deficits6 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.