Tuberculum Sellae Meningioma Clinical Trial
— PRONOPTICOfficial title:
Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal
| NCT number | NCT03567486 |
| Other study ID # | DCT_2017_18 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 18, 2017 |
| Est. completion date | January 2024 |
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
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | January 2024 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - tuberculum sellae meningioma surgical indication Exclusion Criteria: - surgical contra indication MRI contra indication optical disease |
| Country | Name | City | State |
|---|---|---|---|
| France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | variation of Visual field | between before surgery and 6 months postoperatively |