Prospective Study Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye

Glaucoma Clinical Trial

Official title:

Prospective Study Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01348672
• Other study ID #: ORF2
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2011
• Last updated: January 16, 2013
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2013
• Source: University of Toronto
• Contact: Chris Hudson, Ph.D
• Phone: 416 603 5694
• Email: chudson[@]uwaterloo.ca
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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 the investigators international academic and private sector partners, the investigators 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 the investigators 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.

Description:

This research will add to our basic knowledge in predicting the development of sight-threatening change in patient with the ARMD, diabetic retinopathy and primary open glaucoma, 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. 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:

• Comprehensively assess the blood supply to, and vascular regulation characteristics of the posterior segment of the eye, a diagnostic capability that is currently severely limited.

• Assess oxygen saturation disturbances in the retina and ON that occur prior to clinically detectable changes, diagnostic capability that currently does not exist

• Using the retinal blood supply and oxygen saturation parameters, we will derive net oxygen delivery to the retina and optic nerve head (ONH), a diagnostic capability that does not exist.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 381
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion criteria:

• Subjects diagnosed with age related macular degeneration

• Subjects diagnosed with glaucoma

• Subjects diagnosed with diabetic retinopathy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Diabetic Retinopathy
• Diabetic Retinopathy.
• Glaucoma
• Macular Degeneration
• Retinal Diseases

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Ontario Research Fund

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. — View Citation

Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33. — View Citation

Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. — View Citation

Klein R, Wang Q, Klein BE, Moss SE, Meuer SM. The relationship of age-related maculopathy, cataract, and glaucoma to visual acuity. Invest Ophthalmol Vis Sci. 1995 Jan;36(1):182-91. — View Citation

Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry	To investigate the cross-sectional relationship between retinal / ON oxygen saturation, vascular dysregulation and retinal morphometry in groups of patients at risk of progres	5 years	No
Primary	Prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes	To establish the prospective relationship between retinal/ON oxygen saturation disturbances, vascular dysregulation, retinal morphometry and clinical outcomes in patients at risk of progression of ARMD, POAG and DR and age-matched healthy controls	5 years	No
Primary	Topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters	To investigate the topographic distribution of retinal / ON oxygen saturation disturbance, vascular dysfunction and change in morphometric parameters in groups of patients at risk of progression of ARMD, POAG and DR	5 years	No