Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

June 11, 2020 updated by: Gilda Cennamo, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 45 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.

Description

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

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 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)
48 hours

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 1, 2019

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT 2006/20

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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