Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
NCT ID: NCT00712842
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2007-01-31
2011-12-31
Brief Summary
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Various animal and human studies have demonstrated that retinal and optic nerve blood flow increase in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies describe the effects of flickering light on retinal and optic nerve head blood flow, the knowledge about this coupling in the diabetic retina is sparse.
In view of the fact that neural activity and blood flow are strongly coupled in the human retina, one could hypothesize that neurodegenerative changes in the retina could contribute to the vascular dysregulation and in turn lead to changes of ocular perfusion. The investigators set out to investigate whether the coupling of neural activity and blood flow is impaired in patients with early stage diabetic retinopathy compared to those in healthy volunteers.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients with non or mild non-proliferative diabetic retinopathy
Ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
2
Healthy control subjects
Ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
Interventions
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Ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
Eligibility Criteria
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Inclusion Criteria
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Men and women will be included in equal parts. A pregnancy test will be performed at screening
* Ametropia of less than 3 diopters and anisometropia of less than 1 diopter
Exclusion Criteria
* Maturity onset diabetes of the young (MODY diabetes)
* Any sign of non diabetes induced vascular pathologies, systemic hypertension (defined as systolic blood pressure \> 150 mm Hg and diastolic blood pressure \> 90 mm Hg.)
* Presence of intraocular pathology other than diabetic retinopathy
* History or family history of epilepsy
* Pregnancy
20 Years
50 Years
ALL
Yes
Sponsors
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Gerhard Garhofer
OTHER
Responsible Party
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Gerhard Garhofer
MD
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Vienna, Austria
Countries
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References
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Lasta M, Pemp B, Schmidl D, Boltz A, Kaya S, Palkovits S, Werkmeister R, Howorka K, Popa-Cherecheanu A, Garhofer G, Schmetterer L. Neurovascular dysfunction precedes neural dysfunction in the retina of patients with type 1 diabetes. Invest Ophthalmol Vis Sci. 2013 Jan 30;54(1):842-7. doi: 10.1167/iovs.12-10873.
Other Identifiers
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OPHT-221203
Identifier Type: -
Identifier Source: org_study_id