Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Completed

• Conditions: Pituitary Adenoma

• Registration Number: NCT04840771
• Lead Sponsor: Federico II University

Brief Summary

This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description

The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-31
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• age older than 40 years
• diagnosis of pituitary adenoma
• treatment-naïve with Endoscopic Endonasal Pituitary Surgery
• absence of other neurological diseases
• absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria

• age younger than 40 years
• No diagnosis of pituitary adenoma
• previous treatments with Endoscopic Endonasal Pituitary Surgery
• presence of neurological diseases
• presence of vitreoretinal and vascular retinal diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery	48 hours and 1 year follow up	8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery	48 hours and 1 year follow up	8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

Secondary Outcome Measures

Name	Time	Method
Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery	1 year follow up	8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.; Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery	1 year follow up	8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.; Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery.

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy