NCT00328835

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
Last Updated

October 17, 2006

Status Verified

May 1, 2006

First QC Date

May 18, 2006

Last Update Submit

October 16, 2006

Conditions

Keywords

Optic NerveGlaucoma

Outcome Measures

Primary Outcomes (2)

  • Optic Disc Change

  • Visual Field Progression

Secondary Outcomes (1)

  • Visual Acuity Change

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • Wells 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.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Anthony P Wells, FRANZCO

    CVRT, Wellington School Of Medicine - University of Otago

    PRINCIPAL INVESTIGATOR

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

Locations