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Completed

NCT Number: NCT04840771

Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

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.

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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Endonasal Pituitary Surgery

Procedure

Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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