Neurovascular Coupling in Patients With Early Stage Diabetes Retinopathy

NCT00712842 | Completed DMC

• 1 other identifier: OPHT-221203
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes; ocular blood flow

Outcome Measures

Primary Outcomes (4)

• Intraocular pressure

  90 minutes

• Retinal arterial and venous diameter

  90 minutes

• Retinal blood velocity

  90 minutes

• Pattern ERG

  measured once on the study day

Secondary Outcomes (2)

• Mean arterial pressure

  90 minutes

• Blood glucose

  measured once on the study day

Study Arms (2)

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

Ocular blood flow measurements OTHER

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

1; 2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 Patients with Diabetes Type 1 50 Healthy Control Subjects

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerhard Garhofer: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 23307962 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 10, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

AU (1)