Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

Glaucoma Open-Angle Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Open-Angle
• Glaucoma, Open-Angle

• NCT number: NCT00306657
• Study type: Interventional
• Source: Kantonsspital Aarau
• Contact: Hanspeter E Killer, MD, Prof
• Phone: +41628385021
• Email: killer@ksa.ch
• Status: Recruiting
• Phase: N/A
• Start date: March 2006
• Completion date: December 2012