Predictive Factors of Visual Recovery After Paraoptic Tumors Removal (PRONOPTIC)

December 12, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

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
      • Paris, France, 75019
        • Recruiting
        • Fondation Ophtalmologique Adolphe de Rothschild
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

tuberculum sellae meningioma

Description

Inclusion Criteria:

  • tuberculum sellae meningioma surgical indication

Exclusion Criteria:

  • surgical contra indication MRI contra indication optical disease

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Tuberculum sellae meningiomas
Adult patient suffering from tuberculum sellae meningiomas with surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
variation of Visual field
Time Frame: between before surgery and 6 months postoperatively
between before surgery and 6 months postoperatively

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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)

December 18, 2017

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCT_2017_18

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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