Clinical trial · Interventional
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches
Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Optic Nerve Injuries | — | UNRESOLVED | — |
| Sellar Tumor | Sellar Region Neoplasm | ALIAS | 0.90 |
| Skull Base Neoplasms | Skull Base Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optic Nerve Stimulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Optic Nerve Stimulation
- description
- 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.
- interventionNames
- Procedure: Optic Nerve Stimulation
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series.
Primary outcomes (1)
- measure
- Visual Deficits
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (11)
- BACKGROUNDMargalit 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. PMID 12943569
- BACKGROUNDCohen 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. PMID 4047355
- BACKGROUNDJashek-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. PMID 34301198
- BACKGROUNDNewman 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. PMID 18427624
- BACKGROUNDCarnevale 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. PMID 34598134
- BACKGROUNDSakata 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. PMID 37423756
- BACKGROUNDChung 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.