Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Optic Nerve Stimulation

    Procedure/Surgery

    Anterograde Stimulation of the Optic Neve.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Optic Nerve StimulationExperimental treatment 1 intervention
Group B: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Visual Deficits

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.

Time frame
6 weeks after surgery date.

Secondary outcomes

Other outcomes

Sponsors and contacts

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