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Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

Normal Tension and Chronic Open Angle Glaucoma, Cerebrospinal Fluid Composition in Subarachnoid Space of Affected Optic Nerves

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00306657
Enrollment
30
Registered
2006-03-24
Start date
2006-03-31
Completion date
2012-12-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

Sponsors

Kantonsspital Aarau
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Visual acuity
Visual field
Quality of life assessment
Laboratory markers work-up

Countries

Switzerland

Contacts

Primary ContactHanspeter E Killer, MD, Prof
killer@ksa.ch+41628385021
Backup ContactGregor P Jaggi, MD
gregor.jaggi@gmx.ch+41763261306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026