Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306657
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2006-03-23
Brief Title:
Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition
Sponsor:
Kantonsspital Aarau
Organization:
Kantonsspital Aarau
Study Overview
Official Title:
Normal Tension and Chronic Open Angle Glaucoma Cerebrospinal Fluid Composition in Subarachnoid Space of Affected Optic Nerves
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Normal tension glaucoma NTG and chronic open angle glaucoma COAG occurring progressively with optimal conventional or intraocular pressure reducing surgery are still unsolved problems in ophthalmology The investigators would like to investigate whether or not the composition of cerebrospinal fluid CSF surrounding the optic nerve ON in these patients is pathologic under certain conditions They therefore compare the CSF taken during optic nerve sheath fenestration with the CSF taken during a lumbar puncture The investigators hypothesis is that in patients with NTG and COAG the composition of CSF surrounding the affected ON plays an important role in promoting progressive visual function loss
Detailed Description:
We will recruit 30 patients with progressive visual function loss due to Normal tension glaucoma NTG or chronic open angle glaucoma COAG despite optimal conventional or intraocular pressure reducing surgery treatment so far We will proceed with an optic nerve sheath fenestration ONSF according to the studies in the literature eg Wax MB Barrett DA Hart WM Jr Custer PL Optic nerve sheath decompression for glaucomatous optic neuropathy with normal intraocular pressure Arch Ophthalmol 199311191219-28 and compare the cerebrospinal fluid CSF taken from the subarachnoid space SAS of the optic nerve ON with the CSF taken during a lumbar puncture on the same day Concentrations of neurobioactive substances will especially be studied Visual acuity and visual field development before and after ONSF will be studied Quality of life assessment will be done before and several times after ONSF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None