NCT04074642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2023

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

August 20, 2019

Last Update Submit

March 20, 2026

Conditions

Pituitary Adenoma

Keywords

macroadenoma

Outcome Measures

Primary Outcomes (2)

  • change of middle deviation

    visual field evolution assessed by Middle deviation

    before surgery (= inclusion), 4 months after surgery and 10 months after surgery

  • 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

Study Arms (2)

Non compressive adenoma

NO INTERVENTION

Optical Coherence Tomography Angiography without surgery

Compressive adenoma

EXPERIMENTAL

Optical Coherence Tomography Angiography before and after neurosurgery

Procedure: Neurosurgery

Interventions

NeurosurgeryPROCEDURE

adenoma removal

Compressive adenoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • retinian disease
  • amblyopia
  • parkinson disease
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de NICE

Nice, 06000, France

Location

Hôpital Pasteur 2 - Service d'Ophtalmologie

Nice, 06001, France

Location

Related Publications (1)

  • Toumi E, Almairac F, Mondot L, Themelin A, Decoux-Poullot AG, Paquis P, Chevalier N, Baillif S, Nahon-Esteve S, Martel A. Benefit of Optical Coherence Tomography-Angiography in Patients Undergoing Transsphenoidal Pituitary Adenoma Surgery: A Prospective Controlled Study. Diagnostics (Basel). 2024 Aug 12;14(16):1747. doi: 10.3390/diagnostics14161747.

    PMID: 39202235RESULT

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Neurosurgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • ARNAUD MARTEL

    ophtalmology department, Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 30, 2019

Study Start

November 14, 2019

Primary Completion

February 22, 2023

Study Completion

February 22, 2023

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

FR(2)