Normal Tension and Chronic Open Angle Glaucoma and Cerebr... | NCT00306657

Studies
Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

NCT00306657

Sponsor

Kantonsspital Aarau

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Glaucoma Open-Angle

Interventions

Optic nerve sheath fenestration

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2012Estimated

First Submitted Date

Mar 23, 2006

First Submission Date that Met QC Criteria

Mar 23, 2006

First Posted Date

Mar 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Optic nerve sheath fenestration	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity
Visual field
Quality of life assessment
Laboratory markers work-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hanspeter E Killer, MD, Prof	Contact	+41628385021		killer@ksa.ch
Gregor P Jaggi, MD	Contact	+41763261306		gregor.jaggi@gmx.ch

Overall Officials

Name	Affiliation	Role
Hanspeter E Killer, MD, Prof	Kantonsspital Aarau, Department of ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Aarau, Department of Ophthalmology, Switzerland	Recruiting	Aarau	Canton of Aargau	5001	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8363465	Background	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. doi: 10.1001/archopht.1993.01090090071022.
21398413	Derived	Jaggi GP, Miller NR, Flammer J, Weinreb RN, Remonda L, Killer HE. Optic nerve sheath diameter in normal-tension glaucoma patients. Br J Ophthalmol. 2012 Jan;96(1):53-6. doi: 10.1136/bjo.2010.199224. Epub 2011 Mar 11.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases