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Clinical Trials/NCT04546386
NCT04546386
Completed
Not Applicable

Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography

Federico II University1 site in 1 country14 target enrollmentJanuary 10, 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 retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description

The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve. The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Registry
clinicaltrials.gov
Start Date
January 10, 2019
End Date
March 25, 2020
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-naive with endoscopic endonasal pituitary surgery
  • absence of other neurological disease
  • absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria

  • age younger than 45 years
  • No diagnosis of pituitary adenoma
  • previous treatment with endoscopic endonasal pituitary surgery
  • presence of neurological disease
  • presence of vitreretinal and vascular retinal diseases

Outcomes

Primary Outcomes

Study of vessel density of the retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up.

Time Frame: one year

To evaluate the changes in vessel density of the retinal vascular network 48 hours and 1 year after endoscopic endonasal pituitary surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was the vessel density of the retinal vascular network.

Study Sites (1)

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