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Optic Nerve Compliance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328835
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : October 17, 2006
Information provided by:
Capital Vision Research Trust

Brief Summary:
Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed world. It is a condition where long term exposure to high eye pressures (intra-ocular pressure) damages the nerve fibres in the eye. This damage can be seen by examiners as changes in the optic nerve. The exact mechanism of how the high intra-ocular pressure causes nerve damage is unknown. Both physiological and mechanical mechanisms are thought to play a role. Previous authors have reported structural changes in the connective tissue of optic nerves of eyes with glaucoma. Structural changes in the optic nerve head which affect the mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve damage. This study aims to assess the compliance of the optic disc in subjects with and without glaucoma. We would test compliance by imaging the optic discs of participants before and during a brief (less than two minutes) increase in intra-ocular pressure. We would aim to repeat the tests on the same subjects 3 years later to see how compliance changed. We would also seek to correlate other important parameters such as corneal thickness and visual field changes with our findings

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Brief Elevation of IOP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Optic Nerve Compliance Study
Study Start Date : March 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. Optic Disc Change
  2. Visual Field Progression

Secondary Outcome Measures :
  1. Visual Acuity Change

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Age over 18, Diagnosis of glaucoma (visual field proven), Stable, well controlled glaucoma

Exclusion Criteria:

  • Previous eye surgery, Best corrected visual acuity <6/9, Chronic eye disease (including glaucoma, Secondary glaucoma (eg uveitis, neovascular glaucoma, etc), Advanced or fixation-threatening visual field changes, Ocular perfusion abnormalities (e.g. previous retinal artery or vein occlusion; or abnormal vasculature including those whose retinal circulation might be compromised by pressure on the eye).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328835

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New Zealand
Capital Vision Research Trust
Wellington, New Zealand, 6001
Sponsors and Collaborators
Capital Vision Research Trust
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Principal Investigator: Anthony P Wells, FRANZCO CVRT, Wellington School Of Medicine - University of Otago
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00328835    
Other Study ID Numbers: ONCS
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: October 17, 2006
Last Verified: May 2006
Keywords provided by Capital Vision Research Trust:
Optic Nerve
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases