Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 23, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 27, 2011
April 1, 2007
March 23, 2006
June 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Visual acuity
Visual field
Quality of life assessment
Laboratory markers work-up
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Aarau, Department of Ophthalmology, Switzerland
Aarau, Canton of Aargau, 5001, Switzerland
Related Publications (2)
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.
PMID: 8363465BACKGROUNDJaggi 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.
PMID: 21398413DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanspeter E Killer, MD, Prof
Kantonsspital Aarau, Department of ophthalmology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2006
First Posted
March 24, 2006
Study Start
March 1, 2006
Study Completion
December 1, 2012
Last Updated
June 27, 2011
Record last verified: 2007-04