Optic Nerve InjuriesNCT06495580
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches
A study testing Optic Nerve Stimulation in people with Optic Nerve Injuries and Sellar Tumor, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Nerve Injuries, Sellar Tumor, Skull Base Neoplasms
- What is being tested?
- Optic Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Daniel Quintana, 909-441-8999, Daniel.Quintana@ucsf.edu
About this study
Official title: Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in 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 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.
Read the 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 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.
- Conditions
- Optic Nerve Injuries, Sellar Tumor, Skull Base Neoplasms
- Being tested
- Optic Nerve Stimulation
- Medical subject headings
- Optic Nerve Injuries, Skull Base Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic Nerve StimulationProcedure or surgery
Anterograde Stimulation of the Optic Neve.
| Study group | Role | What they receive |
|---|---|---|
| Optic Nerve Stimulation | Experimental | The most significant procedure will be using an anterograde microstimulator and provoke stimulations to the optic nerve as the surgery proceeds. During surgery, the optic nerve and chiasm will be stimulated and the response recorded in both eyes and occipital cortex via skin electrodes. These responses will be monitored at all times by the neuromonitorig team who will inform if changes in neural responses change. The use of microstimulator has been proven safe in other surgical approaches. Receives: Procedure: Optic Nerve Stimulation |
| No Intervention | No intervention | Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after surgery date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study will enroll adult (18 y.o. and older) patients undergoing open or endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezequiel Goldschmidt, MD, PhD, Principal investigator, UCSF Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495580
- Sponsor's protocol ID
- 24-41739
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margalit NS, Lesser JB, Moche J, Sen C. Meningiomas involving the optic nerve: technical aspects and outcomes for a series of 50 patients. Neurosurgery. 2003 Sep;53(3):523-32; discussion 532-3. doi: 10.1227/01.neu.0000079506.75164.f4.
PubMed 12943569Cohen AR, Cooper PR, Kupersmith MJ, Flamm ES, Ransohoff J. Visual recovery after transsphenoidal removal of pituitary adenomas. Neurosurgery. 1985 Sep;17(3):446-52. doi: 10.1227/00006123-198509000-00008.
PubMed 4047355Jashek-Ahmed F, Cabrilo I, Bal J, Sanders B, Grieve J, Dorward NL, Marcus HJ. Intraoperative monitoring of visual evoked potentials in patients undergoing transsphenoidal surgery for pituitary adenoma: a systematic review. BMC Neurol. 2021 Jul 23;21(1):287. doi: 10.1186/s12883-021-02315-4.
PubMed 34301198Newman S. A prospective study of cavernous sinus surgery for meningiomas and resultant common ophthalmic complications (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2007;105:392-447.
PubMed 18427624Carnevale JA, Babu CS, Goldberg JL, Fong R, Schwartz TH. Visual deterioration after endonasal endoscopic skull base surgery: causes, treatments, and outcomes. J Neurosurg. 2021 Oct 1;136(4):1103-1113. doi: 10.3171/2021.3.JNS204378. Print 2022 Apr 1.
PubMed 34598134Sakata K, Komaki S, Takeshige N, Negoto T, Kikuchi J, Kajiwara S, Orito K, Nakamura H, Hirohata M, Morioka M. Visual Outcomes and Surgical Approach Selection Focusing on Active Optic Canal Decompression and Maximum Safe Resection for Suprasellar Meningiomas. Neurol Med Chir (Tokyo). 2023 Sep 15;63(9):381-392. doi: 10.2176/jns-nmc.2021-0142. Epub 2023 Jul 10.
PubMed 37423756Chung SB, Park CW, Seo DW, Kong DS, Park SK. Intraoperative visual evoked potential has no association with postoperative visual outcomes in transsphenoidal surgery. Acta Neurochir (Wien). 2012 Aug;154(8):1505-10. doi: 10.1007/s00701-012-1426-x. Epub 2012 Jun 29.
PubMed 22739773Qiao N, Yang X, Li C, Ma G, Kang J, Liu C, Cao L, Zhang Y, Gui S. The predictive value of intraoperative visual evoked potential for visual outcome after extended endoscopic endonasal surgery for adult craniopharyngioma. J Neurosurg. 2021 May 7;135(6):1714-1724. doi: 10.3171/2020.10.JNS202779. Print 2021 Dec 1.
PubMed 33962373Benedicic M, Bosnjak R. Intraoperative monitoring of the visual function using cortical potentials after electrical epidural stimulation of the optic nerve. Acta Neurochir (Wien). 2011 Oct;153(10):1919-27. doi: 10.1007/s00701-011-1098-y. Epub 2011 Aug 5.
PubMed 21818643Sasaki T, Itakura T, Suzuki K, Kasuya H, Munakata R, Muramatsu H, Ichikawa T, Sato T, Endo Y, Sakuma J, Matsumoto M. Intraoperative monitoring of visual evoked potential: introduction of a clinically useful method. J Neurosurg. 2010 Feb;112(2):273-84. doi: 10.3171/2008.9.JNS08451.
PubMed 19199497Benedicic M, Bosnjak R. Optic nerve potentials and cortical potentials after stimulation of the anterior visual pathway during neurosurgery. Doc Ophthalmol. 2011 Apr;122(2):115-25. doi: 10.1007/s10633-011-9265-2. Epub 2011 Mar 16.
PubMed 21409432
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches
- ClinicalTrials.gov ID
- NCT06495580
- Acronym / sponsor ID
- 24-41739
- Conditions
- Optic Nerve Injuries, Sellar Tumor, Skull Base Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll adult (18 y.o. and older) patients undergoing open or endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas
| Arm | Type | Receives |
|---|---|---|
| Optic Nerve Stimulation | Experimental | Procedure: Optic Nerve StimulationThe most significant procedure will be using an anterograde microstimulator and provoke stimulations to the optic nerve as the surgery proceeds. During surgery, the optic nerve and chiasm will be stimulated and the response recorded in both eyes and occipital cortex via skin electrodes. These responses will be monitored at all times by the neuromonitorig team who will inform if changes in neural responses change. The use of microstimulator has been proven safe in other surgical approaches. |
| No Intervention | No intervention | –Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic Nerve StimulationAnterograde Stimulation of the Optic Neve. | Procedure or surgery | Optic Nerve Stimulation |
Primary outcome
Visual Deficits
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 12943569Margalit NS, Lesser JB, Moche J, Sen C. Meningiomas involving the optic nerve: technical aspects and outcomes for a series of 50 patients. Neurosurgery. 2003 Sep;53(3):523-32; discussion 532-3. doi: 10.1227/01.neu.0000079506.75164.f4.
- Background: PubMed 4047355Cohen AR, Cooper PR, Kupersmith MJ, Flamm ES, Ransohoff J. Visual recovery after transsphenoidal removal of pituitary adenomas. Neurosurgery. 1985 Sep;17(3):446-52. doi: 10.1227/00006123-198509000-00008.
- Background: PubMed 34301198Jashek-Ahmed F, Cabrilo I, Bal J, Sanders B, Grieve J, Dorward NL, Marcus HJ. Intraoperative monitoring of visual evoked potentials in patients undergoing transsphenoidal surgery for pituitary adenoma: a systematic review. BMC Neurol. 2021 Jul 23;21(1):287. doi: 10.1186/s12883-021-02315-4.
- Background: PubMed 18427624Newman S. A prospective study of cavernous sinus surgery for meningiomas and resultant common ophthalmic complications (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2007;105:392-447.
- Background: PubMed 34598134Carnevale JA, Babu CS, Goldberg JL, Fong R, Schwartz TH. Visual deterioration after endonasal endoscopic skull base surgery: causes, treatments, and outcomes. J Neurosurg. 2021 Oct 1;136(4):1103-1113. doi: 10.3171/2021.3.JNS204378. Print 2022 Apr 1.
- Background: PubMed 37423756Sakata K, Komaki S, Takeshige N, Negoto T, Kikuchi J, Kajiwara S, Orito K, Nakamura H, Hirohata M, Morioka M. Visual Outcomes and Surgical Approach Selection Focusing on Active Optic Canal Decompression and Maximum Safe Resection for Suprasellar Meningiomas. Neurol Med Chir (Tokyo). 2023 Sep 15;63(9):381-392. doi: 10.2176/jns-nmc.2021-0142. Epub 2023 Jul 10.
- Background: PubMed 22739773Chung SB, Park CW, Seo DW, Kong DS, Park SK. Intraoperative visual evoked potential has no association with postoperative visual outcomes in transsphenoidal surgery. Acta Neurochir (Wien). 2012 Aug;154(8):1505-10. doi: 10.1007/s00701-012-1426-x. Epub 2012 Jun 29.
- Background: PubMed 33962373Qiao N, Yang X, Li C, Ma G, Kang J, Liu C, Cao L, Zhang Y, Gui S. The predictive value of intraoperative visual evoked potential for visual outcome after extended endoscopic endonasal surgery for adult craniopharyngioma. J Neurosurg. 2021 May 7;135(6):1714-1724. doi: 10.3171/2020.10.JNS202779. Print 2021 Dec 1.
- Background: PubMed 21818643Benedicic M, Bosnjak R. Intraoperative monitoring of the visual function using cortical potentials after electrical epidural stimulation of the optic nerve. Acta Neurochir (Wien). 2011 Oct;153(10):1919-27. doi: 10.1007/s00701-011-1098-y. Epub 2011 Aug 5.
- Background: PubMed 19199497Sasaki T, Itakura T, Suzuki K, Kasuya H, Munakata R, Muramatsu H, Ichikawa T, Sato T, Endo Y, Sakuma J, Matsumoto M. Intraoperative monitoring of visual evoked potential: introduction of a clinically useful method. J Neurosurg. 2010 Feb;112(2):273-84. doi: 10.3171/2008.9.JNS08451.
- Background: PubMed 21409432Benedicic M, Bosnjak R. Optic nerve potentials and cortical potentials after stimulation of the anterior visual pathway during neurosurgery. Doc Ophthalmol. 2011 Apr;122(2):115-25. doi: 10.1007/s10633-011-9265-2. Epub 2011 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ezequiel Goldschmidt, MD, PhD principal investigator
UCSF Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic Nerve Stimulation in people with Optic Nerve Injuries and Sellar Tumor, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ezequiel Goldschmidt, MD, PhD (415.514.6482, eze.goldschmidt@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Deficits (time frame: 6 weeks after surgery date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495580, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.