ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery

Not yet recruiting

• Conditions: Indocyanine Green; Skull Base Neoplasms
• Interventions: Procedure: Indocyanine Green

• Registration Number: NCT06501716
• Lead Sponsor: University of California, San Francisco

Brief Summary

Endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves (ON). Surgery often involves dissecting tumors from the optic nerves and its blood supply, which can result in nerve damage and visual loss after surgery. To date, there are no reliable methods to monitor the optic nerve function during surgery and thus, post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam. This delay in diagnosis prevents early therapeutic measures and can result in further harm to the ON. We have recently recognized that when ICG is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying (SHA) the ON are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery. Thus, ICG may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap. This study will assess whether endoscopic ICG angiography before and after resection of suprasellar lesions can predict post-operative visual deficits. Successful completion will provide surgeons a novel tool to assess visual function during surgery. The ICG endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-30
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.

Exclusion Criteria

• Underage patients (younger than 18 y.o).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICG Group	Indocyanine Green	Eligible participants are those diagnosed with suprasellar lesions undergoing ICG angiography during endoscopic endonasal resection.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients with Post Operative Visual Acuity Impairment and Visual Field Defect	From the surgery to first post-operative follow up (6 weeks)	The investigators will evaluate the percentage of participants that present with decreased of visual acuity and any modality of visual field defect after the surgery. Postoperative visual acuity and visual field testing will be performed at 6 weeks postoperative follow up visit to evaluate chiasm function, including cranial nerve examination, bilateral number counting, letter reading, and number identification in 4 quadrants of peripheral vision. Visual evaluations will be performed by the ophthalmology service following our standard postoperative protocol.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States