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Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00712842
First received: July 7, 2008
Last updated: July 19, 2012
Last verified: July 2012

July 7, 2008
July 19, 2012
January 2007
September 2011   (final data collection date for primary outcome measure)
  • Intraocular pressure [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Retinal arterial and venous diameter [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Retinal blood velocity [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Pattern ERG [ Time Frame: measured once on the study day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00712842 on ClinicalTrials.gov Archive Site
  • Mean arterial pressure [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]
  • Blood glucose [ Time Frame: measured once on the study day ] [ Designated as safety issue: Yes ]
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Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy
Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

50 Patients with Diabetes Type 1 50 Healthy Control Subjects

Diabetic Retinopathy
Other: Ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters and laser Doppler velocimetry
  • 1
    Patients with non or mild non-proliferative diabetic retinopathy
    Intervention: Other: Ocular blood flow measurements
  • 2
    Healthy control subjects
    Intervention: Other: Ocular blood flow measurements
Lasta M, Pemp B, Schmidl D, Boltz A, Kaya S, Palkovits S, Werkmeister R, Howorka K, Popa-Cherecheanu A, Garhöfer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00712842
OPHT-221203
Yes
Gerhard Garhofer, Medical University of Vienna
Gerhard Garhofer
Not Provided
Not Provided
Medical University of Vienna
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP