Optic Nerve Compliance Study
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 18, 2006
CompletedFirst Posted
Study publicly available on registry
May 22, 2006
CompletedOctober 17, 2006
May 1, 2006
May 18, 2006
October 16, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Optic Disc Change
Visual Field Progression
Secondary Outcomes (1)
Visual Acuity Change
Interventions
Eligibility Criteria
You may qualify if:
- Age over 18, Diagnosis of glaucoma (visual field proven), Stable, well controlled glaucoma
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Vision Research Trust
Wellington, 6001, New Zealand
Related Publications (2)
Poostchi A, Wong T, Chan KC, Kedzlie L, Sachdev N, Nicholas S, Garway-Heath DF, Wells AP. Optic disc diameter increases during acute elevations of intraocular pressure. Invest Ophthalmol Vis Sci. 2010 May;51(5):2313-6. doi: 10.1167/iovs.09-3756. Epub 2009 Nov 11.
PMID: 19907027DERIVEDWells AP, Garway-Heath DF, Poostchi A, Wong T, Chan KC, Sachdev N. Corneal hysteresis but not corneal thickness correlates with optic nerve surface compliance in glaucoma patients. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3262-8. doi: 10.1167/iovs.07-1556. Epub 2008 Mar 3.
PMID: 18316697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony P Wells, FRANZCO
CVRT, Wellington School Of Medicine - University of Otago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2006
First Posted
May 22, 2006
Study Start
March 1, 2006
Study Completion
April 1, 2006
Last Updated
October 17, 2006
Record last verified: 2006-05