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

Not Applicable

Completed

• Conditions: Pituitary Adenoma
• Interventions: Procedure: Neurosurgery

• Registration Number: NCT04074642
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Start: 2019-11-14
• Primary Completion: 2023-02-22
• Study Completion: 2023-02-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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Exclusion Criteria

• retinian disease
• amblyopia
• parkinson disease
• pregnant woman

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compressive adenoma	Neurosurgery	Optical Coherence Tomography Angiography before and after neurosurgery

Primary Outcome Measures

Name	Time	Method
change of middle deviation	before surgery (= inclusion), 4 months after surgery and 10 months after surgery	visual field evolution assessed by Middle deviation
Change of visual function index	before surgery (= inclusion), 4 months after surgery and 10 months after surgery	visual field evolution assessed by visual function index

Trial Locations

Locations (2)

Hôpital Pasteur 2 - Service d'Ophtalmologie; 🇫🇷 Nice, France

CHU de NICE; 🇫🇷 Nice, France