Clinical Trials Directory

Trials / Completed

CompletedNCT04840771

Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
Federico II University · Academic / Other
Sex
All
Age
40 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic Endonasal Pituitary SurgerySurgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.

Timeline

Start date
2020-06-01
Primary completion
2020-07-30
Completion
2020-07-31
First posted
2021-04-12
Last updated
2021-05-06

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04840771. Inclusion in this directory is not an endorsement.