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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00306657
• Other study ID #: 2005/057
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2006
• Last updated: June 23, 2011
• Start date: March 2006
• Est. completion date: December 2012

Study information

• Verified date: April 2007
• Source: Kantonsspital Aarau
• Contact: Hanspeter E Killer, MD, Prof
• Phone: +41628385021
• Email: killer[@]ksa.ch
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

Procedure:
• Optic nerve sheath fenestration

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau, Department of Ophthalmology, Switzerland	Aarau	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity
Primary	Visual field
Primary	Quality of life assessment
Primary	Laboratory markers work-up

External Links

•   Kantonsspital Aarau, Aargau, Switzerland