Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

Not Applicable

• Conditions: Glaucoma Open-Angle

• Registration Number: NCT00306657
• Lead Sponsor: Kantonsspital Aarau

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-24
• Status Verified: 2007-04
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual acuity
Visual field
Quality of life assessment
Laboratory markers work-up

Trial Locations

Locations (1)

Kantonsspital Aarau, Department of Ophthalmology, Switzerland; 🇨🇭 Aarau, Aargau, Switzerland