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Optic Nerve Compliance Study

This study has been completed.
Sponsor:
Information provided by:
Capital Vision Research Trust
ClinicalTrials.gov Identifier:
NCT00328835
First received: May 18, 2006
Last updated: October 16, 2006
Last verified: May 2006
  Purpose

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 Intervention
Glaucoma
Procedure: Brief Elevation of IOP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Optic Nerve Compliance Study

Resource links provided by NLM:


Further study details as provided by Capital Vision Research Trust:

Primary Outcome Measures:
  • Optic Disc Change
  • Visual Field Progression

Secondary Outcome Measures:
  • Visual Acuity Change

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: April 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328835

Locations
New Zealand
Capital Vision Research Trust
Wellington, New Zealand, 6001
Sponsors and Collaborators
Capital Vision Research Trust
Investigators
Principal Investigator: Anthony P Wells, FRANZCO CVRT, Wellington School Of Medicine - University of Otago
  More Information

No publications provided by Capital Vision Research Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00328835     History of Changes
Other Study ID Numbers: ONCS
Study First Received: May 18, 2006
Last Updated: October 16, 2006
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Capital Vision Research Trust:
Optic Nerve
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014