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Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00712842
Enrollment
100
Registered
2008-07-10
Start date
2007-01-31
Completion date
2011-12-31
Last updated
2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Diabetes, ocular blood flow

Brief summary

A variety of studies demonstrate that ocular blood flow is altered in diabetes and retinal perfusion abnormalities have been proposed to contribute to the pathogenesis of diabetic retinopathy. 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.

Interventions

non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry

Sponsors

Gerhard Garhofer
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women aged between 20 and 50 years * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Duration of Diabetes is between 5 and 20 years * 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

* Non insulin dependent diabetes * 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

Design outcomes

Primary

MeasureTime frame
Intraocular pressure90 minutes
Retinal arterial and venous diameter90 minutes
Retinal blood velocity90 minutes
Pattern ERGmeasured once on the study day

Secondary

MeasureTime frame
Mean arterial pressure90 minutes
Blood glucosemeasured once on the study day

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026