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NCT06495580 · ClinicalTrials.gov registry record · NA

Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

A NA study, sponsored by University of California, San Francisco.

Not yet
Registry status
NA
Development phase
20
Enrollment target

NCT06495580: Clinical Trial NA study, sponsored by University of California, San Francisco.

NCT06495580 is a NA study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06495580, a NA study, has not yet begun recruiting, sponsored by University of California, San Francisco.

NOT YET RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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 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.

Primary Outcome

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.

Interventions

  • PROCEDURE Optic Nerve Stimulation

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-08
Est. Completion 2026-12
Phase NA

What is known before NCT06495580 opens enrollment

NCT06495580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Optic Nerve Stimulation is the first listed.

NCT06495580 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06495580 about?

NCT06495580 is a clinical study titled "Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches". 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 propos...

What is the current status of trial NCT06495580?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-08. Estimated completion is 2026-12.

What interventions are being tested in trial NCT06495580?

The interventions under investigation include: Optic Nerve Stimulation (PROCEDURE).

Who is sponsoring clinical trial NCT06495580?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06495580's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06495580, the US trial registry maintained by the National Library of Medicine. NCT06495580 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.