Ocular Hypertension Clinical Trial
Official title:
Advanced Glycation End Products as a Biomarker for Accelerated Ageing in Glaucomatous Optic Neuropathy
NCT number | NCT02863224 |
Other study ID # | 204642 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | September 2018 |
Verified date | April 2019 |
Source | University of Plymouth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact
pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is
advancing age. The rate of ageing is not the same in all age matched individuals. The concept
of accelerated ageing suggests that the presence of a number of specific genetic,
environmental or systemic risk factors may cumulate to accelerate the ageing process in some
individuals and lead to the development of age-related disease. Understanding the factors
that influence accelerated ageing is vital.
Advanced glycation end products (AGEs) are a complex group of compounds that are naturally
formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the
body where they adversely affect structure and function. Circulating AGE levels can be
influenced by oxidative stress levels and dietary intake. Recent research has found that
sustained exposure to high levels of circulating AGEs could be a major factor in the
development of a number of chronic age-related degenerative disorders, including POAG.
To date there have been few clinical studies that have been able to non-invasively explore
the association between AGE levels and the development and progression of glaucomatous optic
neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary
intake make to total tissue AGE levels in such patients. Furthermore little is understood
about the relationship between AGE levels and retinal vascular function, a parameter known to
be altered in GON that also could be influenced by AGE levels.
The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with
parameters of retinal vascular function, oxidative stress, dietary intake and the presence of
GON. Establishing this association could increase our understanding of the pathogenesis of
GON and allow a new biomarker for accelerated ocular ageing to be realised
Status | Completed |
Enrollment | 131 |
Est. completion date | September 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Must have had an eye test within the last two years - Aged 50+ - Informed, written consent - Have adequate understanding of English language to be able to comprehend the oral and written instructions. - Participants must be able to complete a 12-hour overnight fast, which includes no alcohol or caffeine. Inclusion criteria for Ocular hypertension, Primary open angle glaucoma and normal tension glaucoma: - Follows guidelines set out within the protocol and used at Derriford REI Exclusion Criteria: - Diabetes - Current smokers - History of stroke/TIA - Coronary artery disease/heart failure/arrhythmia/angina - Peripheral vascular disease - Severe dyslipidaemia - Hyper/hypothyroidism |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Plymouth University | Plymouth | Devon |
Lead Sponsor | Collaborator |
---|---|
University of Plymouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tissue bound AGE level (AU) | Level of AGE found in the skin - measured from the lower portion of the arm | Tissue bound AGE level (AU) will be measured for each participant at their second session (within 3 months of volunteering). |
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