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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03567486
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
Tuberculum Sellae Meningioma

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Study Type : Observational
Estimated 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 : December 18, 2017
Estimated Primary Completion Date : June 18, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine

Tuberculum sellae meningiomas
Adult patient suffering from tuberculum sellae meningiomas with surgical treatment

Primary Outcome Measures :
  1. variation of Visual field [ Time Frame: between before surgery and 6 months postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tuberculum sellae meningioma

Inclusion Criteria:

  • tuberculum sellae meningioma surgical indication

Exclusion Criteria:

  • surgical contra indication MRI contra indication optical disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03567486

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Contact: Dorian Chauvet +33 148036915

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Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Dorian Chauvet    +33 148036915   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT03567486     History of Changes
Other Study ID Numbers: DCT_2017_18
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases