Clinical trial NCT00306657: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2006-03-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Visual acuity
measure: Visual field
measure: Quality of life assessment
measure: Laboratory markers work-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau, Department of Ophthalmology, Switzerland
state: Aargau
Study officials:
affiliation: Kantonsspital Aarau, Department of ophthalmology
name: Hanspeter E Killer, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.