Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study. (FIRST)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074642
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.

Condition or disease Intervention/treatment Phase
Pituitary Adenoma Procedure: Neurosurgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
No Intervention: Non compressive adenoma
Optical Coherence Tomography Angiography without surgery
Experimental: Compressive adenoma
Optical Coherence Tomography Angiography before and after neurosurgery
Procedure: Neurosurgery
adenoma removal




Primary Outcome Measures :
  1. change of middle deviation [ Time Frame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery ]
    visual field evolution assessed by Middle deviation

  2. Change of visual function index [ Time Frame: before surgery (= inclusion), 4 months after surgery and 10 months after surgery ]
    visual field evolution assessed by visual function index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pituitary compressive adenoma (for experimental group)
  • pituitary non compressive adenoma

Exclusion Criteria:

  • retinian disease
  • amblyopia
  • parkinson disease
  • pregnant woman

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): NCT04074642


Contacts
Layout table for location contacts
Contact: ARNAUD MARTEL 0492033737 martel.a@chu-nice.fr

Locations
Layout table for location information
France
CHU de NICE Recruiting
Nice, France, 06000
Contact: Arnaud MARTEL, M.D.       martel.a@chu-nice.fr   
Principal Investigator: Arnaud MARTEL, M.D.         
Hôpital Pasteur 2 - Service d'Ophtalmologie Recruiting
Nice, France, 06001
Contact: Arnaud MARTEL, MD       martel.a@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Layout table for investigator information
Principal Investigator: ARNAUD MARTEL ophtalmology department, Nice University Hospital
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04074642    
Other Study ID Numbers: 19-AOI-06
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
macroadenoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Brain Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Vision Disorders
Vision, Low
Pituitary Diseases
Hypothalamic Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms