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Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Kantonsspital Aarau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00306657
First received: March 23, 2006
Last updated: June 23, 2011
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Glaucoma Open-Angle
 Procedure: Optic nerve sheath fenestration

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Normal Tension and Chronic Open Angle Glaucoma, Cerebrospinal Fluid Composition in Subarachnoid Space of Affected Optic Nerves

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Visual acuity
  • Visual field
  • Quality of life assessment
  • Laboratory markers work-up

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306657

Contacts
Contact: Hanspeter E Killer, MD, Prof +41628385021 killer@ksa.ch
Contact: Gregor P Jaggi, MD +41763261306 gregor.jaggi@gmx.ch

Locations
Switzerland
Kantonsspital Aarau, Department of Ophthalmology, Switzerland Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Hanspeter E Killer, MD, Prof     +41628385021     killer@ksa.ch    
Contact: Gregor P Jaggi, MD     +41763261306     gregor.jaggi@gmx.ch    
Principal Investigator: Hanspeter E Killer, MD Prof            
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Principal Investigator: Hanspeter E Killer, MD, Prof Kantonsspital Aarau, Department of ophthalmology
  More Information

Additional Information:
Kantonsspital Aarau, Aargau, Switzerland  This link exits the ClinicalTrials.gov site
ethical committee Aargau, Switzerland  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00306657     History of Changes
Other Study ID Numbers: 2005/057
Study First Received: March 23, 2006
Last Updated: June 23, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Kantonsspital Aarau:
Glaucoma Open-Angle
Normal tension glaucoma progressive
chronic open angle glaucoma progressive
 optic nerve sheath fenestration
cerebrospinal fluid
Beta-Trace Protein

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013