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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546386
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Gilda Cennamo, Federico II University

Brief Summary:
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 pitituary adenoma compressing the optic nerve.

Condition or disease Intervention/treatment
Pituitary Adenoma Procedure: Endoscopic endonasal pitituary surgery

Detailed Description:

The role of the optical coherenc etomography 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 pitituary 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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retinal Vascular Changes After Endoscopic Endonasal Pitituary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • Procedure: Endoscopic endonasal pitituary surgery
    Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter


Primary Outcome Measures :
  1. Study of vessel density of the retinal vascular network in patients underwent endoscopic endonasal pitituary 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 pitituary surgery for the removal of an intra-suprasellar pitituary 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.



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

The partecipants were older than 45 years and they underwent long term follow up after endoscopic endonasal pitituary surgery to remove pitituary adenoma.

They did not present other neurological and ophthalmological diseases

Criteria

Inclusion Criteria:

  • age older than 45 years
  • diagnosis of pitituary adenoma
  • treatment-naive with endoscopic endonasal pitituary surgery
  • absence of other neurological disease
  • absence of vitreretinal and vascular retinal diseases

Exclusion Criteria:

  • age younger than 45 years
  • No diagnosis of pitituary adenoma
  • previous treatment with endoscopic endonasal pitituary surgery
  • presence of neurological disease
  • presence of vitreretinal and vascular retinal diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546386


Locations
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Italy
University of Naples "Federico II"
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Gilda Cennamo Federico II University
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Responsible Party: Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier: NCT04546386    
Other Study ID Numbers: 1003/19
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms