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Clinical Trials/NCT04425954
NCT04425954
Completed
Not Applicable

Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography

Federico II University1 site in 1 country14 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pituitary Adenoma
Sponsor
Federico II University
Enrollment
14
Locations
1
Primary Endpoint
Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description

To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
March 31, 2019
Last Updated
5 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 45 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 45 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

Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Time Frame: 48 hours

To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)

Study Sites (1)

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