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Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT04840771
Collaborator
(none)
8
Enrollment
1
Location
2
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic Endonasal Pituitary Surgery

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 Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Jul 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery [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

  2. Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery [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

Secondary Outcome Measures

  1. Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery [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.

  2. Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples "Federico II" Naples Italy 80100

Sponsors and Collaborators

  • Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier:
NCT04840771
Other Study ID Numbers:
  • 04/21
First Posted:
Apr 12, 2021
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Pituitary Diseases

Study Results

No Results Posted as of May 6, 2021