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Search / Trial NCT06495580

Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 3, 2024

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to monitor the optic nerve during certain brain surgeries to help prevent vision problems. The study involves adult patients who are having surgery for specific types of tumors located near the optic nerve. Researchers want to see if they can safely stimulate the optic nerve during surgery and record its responses, which may help them understand how well the nerve is functioning. By comparing the results from the surgery with the patients' vision after the procedure, they hope to find a better method to protect eyesight during these operations.

To participate in this trial, patients must be diagnosed with certain types of tumors, such as pituitary adenomas or meningiomas, and should not have any existing vision problems. They will undergo either open or endoscopic surgery, which is a less invasive method. Participants can expect to have their vision tested before and after the surgery, and during the operation, doctors will monitor the optic nerve. This study aims to improve patient outcomes and ensure better protection of vision during critical neurosurgical procedures.

Gender

ALL

Eligibility criteria

  • 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.

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Ezequiel Goldschmidt, MD, PhD

Principal Investigator

UCSF Department of Neurological Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported