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

November 15, 2023 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • CHU de Nice
      • Nice, France, 06001
        • Hôpital Pasteur 2 - Service d'Ophtalmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • retinian disease
  • amblyopia
  • parkinson disease
  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before surgery (= inclusion), 4 months after surgery and 10 months after surgery
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
before surgery (= inclusion), 4 months after surgery and 10 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: ARNAUD MARTEL, ophtalmology department, Nice University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Actual)

February 22, 2023

Study Completion (Actual)

February 22, 2023

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-AOI-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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