Back to resultsOCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study. (FIRST)
Primary Purpose
Pituitary Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurosurgery
Sponsored by
About this trial
This is an interventional prevention trial for Pituitary Adenoma focused on measuring macroadenoma
Eligibility Criteria
Inclusion Criteria:
- pituitary compressive adenoma (for experimental group)
- pituitary non compressive adenoma
Exclusion Criteria:
- retinian disease
- amblyopia
- parkinson disease
- pregnant woman
Sites / Locations
- CHU de NICERecruiting
- Hôpital Pasteur 2 - Service d'OphtalmologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non compressive adenoma
Compressive adenoma
Arm Description
Optical Coherence Tomography Angiography without surgery
Optical Coherence Tomography Angiography before and after neurosurgery
Outcomes
Primary Outcome Measures
change of middle deviation
visual field evolution assessed by Middle deviation
Change of visual function index
visual field evolution assessed by visual function index
Secondary Outcome Measures
Full Information
NCT ID
NCT04074642
First Posted
August 20, 2019
Last Updated
January 7, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04074642
Brief Title
OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Acronym
FIRST
Official Title
OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
Keywords
macroadenoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non compressive adenoma
Arm Type
No Intervention
Arm Description
Optical Coherence Tomography Angiography without surgery
Arm Title
Compressive adenoma
Arm Type
Experimental
Arm Description
Optical Coherence Tomography Angiography before and after neurosurgery
Intervention Type
Procedure
Intervention Name(s)
Neurosurgery
Intervention Description
adenoma removal
Primary Outcome Measure Information:
Title
change of middle deviation
Description
visual field evolution assessed by Middle deviation
Time Frame
before surgery (= inclusion), 4 months after surgery and 10 months after surgery
Title
Change of visual function index
Description
visual field evolution assessed by visual function index
Time Frame
before surgery (= inclusion), 4 months after surgery and 10 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pituitary compressive adenoma (for experimental group)
pituitary non compressive adenoma
Exclusion Criteria:
retinian disease
amblyopia
parkinson disease
pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ARNAUD MARTEL
Phone
0492033737
Email
martel.a@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARNAUD MARTEL
Organizational Affiliation
ophtalmology department, Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud MARTEL, M.D.
Email
martel.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Arnaud MARTEL, M.D.
Facility Name
Hôpital Pasteur 2 - Service d'Ophtalmologie
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud MARTEL, MD
Email
martel.a@chu-nice.fr
12. IPD Sharing Statement
Learn more about this trial
OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.
We'll reach out to this number within 24 hrs