Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition
Primary Purpose
Glaucoma Open-Angle
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Optic nerve sheath fenestration
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma Open-Angle focused on measuring Glaucoma Open-Angle, Normal tension glaucoma progressive, chronic open angle glaucoma progressive, optic nerve sheath fenestration, cerebrospinal fluid, Beta-Trace Protein
Eligibility Criteria
Inclusion Criteria: Documented progressive visual function loss over 2 years (visual field or visual acuity) Intraocular pressure measured as a maximum of 25 mmHg Possibility of receiving general anaesthesia and optic nerve sheath fenestration. Exclusion Criteria: Secondary glaucoma Oral medication to lower intraocular pressure (carboanhydrase inhibitor) Visual acuity worse than 20/400 Any other type of glaucoma (pseudoexfoliation, narrow or closed angle).
Sites / Locations
- Kantonsspital Aarau, Department of Ophthalmology, SwitzerlandRecruiting
Outcomes
Primary Outcome Measures
Visual acuity
Visual field
Quality of life assessment
Laboratory markers work-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00306657
Brief Title
Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition
Official Title
Normal Tension and Chronic Open Angle Glaucoma, Cerebrospinal Fluid Composition in Subarachnoid Space of Affected Optic Nerves
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kantonsspital Aarau
4. Oversight
5. Study Description
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, e.g. Wax MB, Barrett DA, Hart WM Jr, Custer PL. Optic nerve sheath decompression for glaucomatous optic neuropathy with normal intraocular pressure. Arch Ophthalmol. 1993;111(9):1219-28.) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Open-Angle
Keywords
Glaucoma Open-Angle, Normal tension glaucoma progressive, chronic open angle glaucoma progressive, optic nerve sheath fenestration, cerebrospinal fluid, Beta-Trace Protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Optic nerve sheath fenestration
Primary Outcome Measure Information:
Title
Visual acuity
Title
Visual field
Title
Quality of life assessment
Title
Laboratory markers work-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented progressive visual function loss over 2 years (visual field or visual acuity)
Intraocular pressure measured as a maximum of 25 mmHg
Possibility of receiving general anaesthesia and optic nerve sheath fenestration.
Exclusion Criteria:
Secondary glaucoma
Oral medication to lower intraocular pressure (carboanhydrase inhibitor)
Visual acuity worse than 20/400
Any other type of glaucoma (pseudoexfoliation, narrow or closed angle).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanspeter E Killer, MD, Prof
Phone
+41628385021
Email
killer@ksa.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor P Jaggi, MD
Phone
+41763261306
Email
gregor.jaggi@gmx.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanspeter E Killer, MD, Prof
Organizational Affiliation
Kantonsspital Aarau, Department of ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau, Department of Ophthalmology, Switzerland
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanspeter E Killer, MD, Prof
Phone
+41628385021
Email
killer@ksa.ch
First Name & Middle Initial & Last Name & Degree
Gregor P Jaggi, MD
Phone
+41763261306
Email
gregor.jaggi@gmx.ch
First Name & Middle Initial & Last Name & Degree
Hanspeter E Killer, MD Prof
12. IPD Sharing Statement
Citations:
PubMed Identifier
8363465
Citation
Wax MB, Barrett DA, Hart WM Jr, Custer PL. Optic nerve sheath decompression for glaucomatous optic neuropathy with normal intraocular pressure. Arch Ophthalmol. 1993 Sep;111(9):1219-28. doi: 10.1001/archopht.1993.01090090071022.
Results Reference
background
PubMed Identifier
21398413
Citation
Jaggi GP, Miller NR, Flammer J, Weinreb RN, Remonda L, Killer HE. Optic nerve sheath diameter in normal-tension glaucoma patients. Br J Ophthalmol. 2012 Jan;96(1):53-6. doi: 10.1136/bjo.2010.199224. Epub 2011 Mar 11.
Results Reference
derived
Links:
URL
http://www.ksa.ch
Description
Kantonsspital Aarau, Aargau, Switzerland
Learn more about this trial
Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition
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