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Completed

NCT Number: NCT04546386

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

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.

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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

45 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

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

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

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. 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Feb 3, 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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