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

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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

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE November 14, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Official Title  ICMJE OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pituitary Adenoma
Intervention  ICMJE Procedure: Neurosurgery
adenoma removal
Study Arms  ICMJE
  • No Intervention: Non compressive adenoma
    Optical Coherence Tomography Angiography without surgery
  • Experimental: Compressive adenoma
    Optical Coherence Tomography Angiography before and after neurosurgery
    Intervention: Procedure: Neurosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • retinian disease
  • amblyopia
  • parkinson disease
  • pregnant woman
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ARNAUD MARTEL 0492033737 martel.a@chu-nice.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04074642
Other Study ID Numbers  ICMJE 19-AOI-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ARNAUD MARTEL ophtalmology department, Nice University Hospital
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP