Central Retinal Vein Occlusion Clinical Trial
Official title:
Phase 1. Validation and Calibration Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye
Canadians fear loss of vision more than any other disability. Vision loss has an enormous impact on quality-of-life and is extremely costly from a societal and economic perspective. In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by 65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial cost of vision loss in Canada is $15.8 billion per year. There is a general perception that vision loss is "normal with aging" but 75% of vision loss is estimated to be preventable. The major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is headed for an epidemic of age-related eye disease and, unless something is done to prepare for this, severe vision loss will have significant consequences in terms of societal and economic costs. Through this proposed Research Program, and in conjunction with our international academic and private sector partners, we will build and develop unique quantitative imaging technologies to permit non-invasive assessment of visual changes, structural changes in the thickness of the retina at the back of the eye and also changes in the amount of blood flowing through the blood vessels that feed the retina with oxygen. This research will add to our basic knowledge in predicting the development of sight-threatening change in patients with the three diseases, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change over time analyses, will be undertaken.
Status | Recruiting |
Enrollment | 275 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 20 to 80 years of age - good vision in at least one eye (equivalent to 20/40 or better when wearing up-to-date spectacles) - normal intraocular pressure (i.e. < 22 mm Hg) - spectacle refraction between +/- 6.00 DS & / or +/- 2.50 DC Exclusion Criteria: - any ocular disease apart from retinal vein / artery occlusion (for stub study #3, patients with retinal vessel occlusion will be recruited) - history of stroke, chronic lung disease (i.e. does not include seasonal asthma) - taking medications with known effects on the blood vessels, other than medications to control blood glucose, blood pressure or cholesterol levels |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Department of Ophthalmology and Vision Science, Toronto Western Research Institute, University Health Network, Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | Ontario Research Fund |
Canada,
Keilhauer CN, Delori FC. Near-infrared autofluorescence imaging of the fundus: visualization of ocular melanin. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3556-64. — View Citation
Slessarev M, Fisher JA, Volgyesi G, Prisman E, Mikulis D, Hudson C, Ansel C (2005). PATENT: A new method and apparatus to attain and maintain target end tidal gas concentrations (WO/2007/012170). International Application #: PCT/CA2005/001166. Filing Date
Tayyari F, Venkataraman ST, Gilmore ED, Wong T, Fisher J, Hudson C. The relationship between retinal vascular reactivity and arteriolar diameter in response to metabolic provocation. Invest Ophthalmol Vis Sci. 2009 Oct;50(10):4814-21. doi: 10.1167/iovs.09-3373. Epub 2009 Apr 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation and calibration of the Quantitative, Doppler SD-OCT Blood Flow Technology | Validation and calibration of the Doppler SD-OCT technology for their optimal utilisation in a clinical setting is required. We aim to explore the signal-to-noise ratio of retinal blood flow and oxygen saturation parameters, generate values to define the impact of absorption, morphological fundus variation and pre-retinal autofluorescence on oxygen saturation imaging and will establish a database of healthy control imaging values for both new technologies and the reproducibility of those measurements. | 1 year | No |
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