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OpenTrials
Completed

NCT Number: NCT04074642

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE, Nice, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • retinian disease
  • amblyopia
  • parkinson disease
  • pregnant woman

Treatment and study plan

Neurosurgery

Procedure

adenoma removal

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: FIRST

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2019
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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