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NCT04074642 Clinical Trial

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

Pituitary Adenoma Clinical Trial

— FIRST  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04074642
Other study ID # 19-AOI-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 14, 2019
Est. completion date February 22, 2023

Study information
Verified date March 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date February 22, 2023
Est. primary completion date February 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - pituitary compressive adenoma (for experimental group) - pituitary non compressive adenoma Exclusion Criteria: - retinian disease - amblyopia - parkinson disease - pregnant woman

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Neurosurgery
adenoma removal

Locations
Country Name City State
France CHU de NICE Nice
France Hôpital Pasteur 2 - Service d'Ophtalmologie Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of middle deviation visual field evolution assessed by Middle deviation before surgery (= inclusion), 4 months after surgery and 10 months after surgery
Primary Change of visual function index visual field evolution assessed by visual function index before surgery (= inclusion), 4 months after surgery and 10 months after surgery
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