The Canadian Glaucoma 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.|
|ClinicalTrials.gov Identifier: NCT00262626|
Recruitment Status : Terminated
First Posted : December 7, 2005
Last Update Posted : December 7, 2005
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Intraocular pressure reduction Procedure: Argon laser trabeculoplasty Procedure: Trabeculectomy||Not Applicable|
Elevated intraocular pressure is the most important known risk factor for the development and progression of open-angle glaucoma. While pressure reduction is beneficial in many cases, a significant proportion of patients continue to progress despite clinically acceptable pressure levels. Many investigators have found no differences in pressure characteristics between progressing and non-progressing patients, highlighting our current inability to identify which patients will respond to pressure reduction. It is likely that this inability stems from our poor understanding of the risk factors, both ocular and systemic, for progression and the probability that glaucoma is a disease with multiple pathogenic mechanisms.
In this application the Canadian Glaucoma Study Group proposes a multi-centre prospective study with the objective of characterising the risk factors associated with the progression of open-angle glaucoma. We will determine sub-groups of patients with regard to the type of progression, thereby allowing us to identify the ocular and systemic profiles of patients who are likely to and not likely to benefit from intraocular pressure reduction.
Our hypotheses are:
(i) The relationship between intraocular pressure characteristics during follow-up and survival rates with regard to progression of open-angle glaucoma is weak.
(ii) Patients with vasospasm have a higher survival rate than patients without vasospasm with the clinical management prescribed in this study.
(iii) Patients with vascular disease have a lower survival rate than patients without vascular disease with the clinical management prescribed in this study.
We will test these hypotheses by following a total of 410 patients in 4 centres (Halifax, Vancouver, Montreal and Toronto) every 4 months for a period of 5 years using a uniform protocol for both the clinical management and study procedures. Clinical management will involve at least 30% reduction in intraocular pressure from the baseline untreated value, followed by an additional 20% or greater reduction after a progressive event. The study procedures include conventional perimetry, blue-on-yellow perimetry and scanning laser tomography of the optic nerve head and nerve fibre layer. We will measure finger blood flow with both heat and cold provocation to assess each patient's susceptibility to vasospasm and also obtain haematological, biochemical and rheological profiles to assess the presence of vascular disease.
Progression of either visual field and optic nerve head damage will be termed a progressive event occurring after a predefined change from baseline. Events will be defined separately for each technique based on percentiles of empirically derived values of test-retest variability, allowing a degree of standardisation between techniques. Comparison of survival times between groups (e.g. vasospastic and non-vasospastic) will be made with Cox's survivorship analysis with a repeated measures model. Where appropriate, group comparisons will be made with the group t-test or Mann-Whitney test.
If we can characterise more fully the risk factors for glaucomatous progression, we may be able to identify the ocular and systemic profiles of patients who will benefit from our current treatment of pressure reduction. More importantly, we can identify the profiles of patients who respond poorly to pressure reduction so that future research efforts can lead to the development and implementation of alternative therapy. We believe that this is a significant study which will result in a better understanding of open-angle glaucoma and help reduce its impact on blindness and visual disability.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||430 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Study on the Risk Factors for the Progression of Open-Angle Glaucoma|
|Study Start Date :||February 1995|
|Study Completion Date :||June 1995|
- Visual field progression
- Optic disc progression
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 ClinicalTrials.gov identifier (NCT number): NCT00262626
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V5Z 3N9|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|University of Toronto|
|Toronto, Ontario, Canada, M5T 2S8|
|University of Montreal|
|Montreal, Quebec, Canada, H1T 2H1|
|Principal Investigator:||Balwantray C Chauhan, Ph.D.||Dalhousie University|