Skip to main content
Clinical Trials/NCT04840771
NCT04840771
Completed
Not Applicable

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

Federico II University1 site in 1 country8 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pituitary Adenoma
Sponsor
Federico II University
Enrollment
8
Locations
1
Primary Endpoint
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gilda Cennamo

Principal Investigator

Federico II University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

Time Frame: 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

Time Frame: 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 Outcomes

  • Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery(1 year follow up)
  • Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery(1 year follow up)

Study Sites (1)

Loading locations...

Similar Trials