Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

May 3, 2021 updated by: Gilda Cennamo, Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 4 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours and 1 year follow up
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
48 hours and 1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery
Time Frame: 1 year follow up

8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.

Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
1 year follow up
Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery
Time Frame: 1 year follow up

8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery.

Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
1 year follow up

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)

June 1, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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