Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.

February 1, 2021 updated by: Gilda Cennamo, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The partecipants were older than 45 years and they underwent long term follow up after endoscopic endonasal pituitary surgery to remove pituitary adenoma.

They did not present other neurological and ophthalmological diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2019

Primary Completion (ACTUAL)

March 10, 2020

Study Completion (ACTUAL)

March 25, 2020

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1003/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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