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PRONOPTIC: Predictive Factors of Visual Recovery After Paraoptic Tumors Removal

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT03567486
Collaborator
(none)
100
Enrollment
1
Location
60
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal
    Actual Study Start Date :
    Dec 18, 2017
    Anticipated Primary Completion Date :
    Aug 18, 2022
    Anticipated Study Completion Date :
    Dec 18, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Tuberculum sellae meningiomas

    Adult patient suffering from tuberculum sellae meningiomas with surgical treatment

    Outcome Measures

    Primary Outcome Measures

    1. variation of Visual field [between before surgery and 6 months postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • tuberculum sellae meningioma surgical indication
    Exclusion Criteria:
    • surgical contra indication MRI contra indication optical disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondation Ophtalmologique Adolphe de Rothschild Paris France 75019

    Sponsors and Collaborators

    • Fondation Ophtalmologique Adolphe de Rothschild

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondation Ophtalmologique Adolphe de Rothschild
    ClinicalTrials.gov Identifier:
    NCT03567486
    Other Study ID Numbers:
    • DCT_2017_18
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Meningioma

    Study Results

    No Results Posted as of Jul 27, 2022