Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Pituitary Adenoma Clinical Trial

Official title:

Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840771
• Other study ID #: 04/21
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 31, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• Endoscopic Endonasal Pituitary Surgery
Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery	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	48 hours and 1 year follow up
Primary	Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery	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	48 hours and 1 year follow up
Secondary	Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery	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.	1 year follow up
Secondary	Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery	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.	1 year follow up