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CompletedNCT00712842Updated Jul 20, 2012

Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

An observational study in Diabetic Retinopathy, sponsored by Gerhard Garhofer. Completed at 1 site in Austria. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Gerhard Garhofer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

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Conditions studied

  • Diabetic Retinopathy

Keywords

  • Diabetes
  • ocular blood flow
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 100 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Gerhard Garhofer is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

50 Patients with Diabetes Type 1 50 Healthy Control Subjects

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • 1

    Patients with non or mild non-proliferative diabetic retinopathy

    Other: Ocular blood flow measurements

  • 2

    Healthy control subjects

    Other: Ocular blood flow measurements

Interventions

  • OtherOcular blood flow measurements

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

06

What researchers measure

Primary outcomes

  1. Intraocular pressure

    Time frame: 90 minutes

  2. Retinal arterial and venous diameter

    Time frame: 90 minutes

  3. Retinal blood velocity

    Time frame: 90 minutes

  4. Pattern ERG

    Time frame: measured once on the study day

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 90 minutes

  2. Blood glucose

    Time frame: measured once on the study day

07

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Publications

  • 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. PubMed 23307962 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00712842
Lead sponsor
Gerhard Garhofer
Responsible party
Gerhard Garhofer (MD, Medical University of Vienna) — Sponsor-investigator
First posted
Jul 10, 2008
Start date
Jan 2007
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Jul 20, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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