Neurovascular Coupling in Patients With Open Angle Glaucoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Terminated
CT.gov ID
NCT00811694
Collaborator
(none)
15
1
67
0.2

Study Details

Study Description

Brief Summary

A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various animal and human studies have shown an increase in retinal and optic nerve head blood flow 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 have confirmed these effects, the knowledge about this coupling in the retina of patients with glaucoma is sparse.

Recently the investigators could show that flicker induced vasodilatation is blunted in patients with open angle glaucoma. However, the investigators results are limited by the fact that only data about retinal vessel diameters, not blood flow per se, are available. The further development of the investigators current flicker stimulation technique now allows us to determine blood flow velocity during flicker stimulation. Thus, in the current study, the investigators set out to determine whether this blood flow response is impaired in patients with glaucoma as compared to those in healthy volunteers and whether this is related to altered neural activity.

The study objective was, to investigate whether the blood flow response to flicker stimulation is altered in patients with glaucoma.

Condition or Disease Intervention/Treatment Phase
  • Other: ocular blood flow measurements

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Official Title:
Neurovascular Coupling in Patients With Open Angle Glaucoma
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
a

15 male and 15 female patients with glaucoma

Other: ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry

b

30 sex matched healthy volunteers

Other: ocular blood flow measurements
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry

Outcome Measures

Primary Outcome Measures

  1. Retinal blood velocity (laser Doppler velocimetry) [measurements done only once on the studyday]

  2. Retinal arterial and venous diameter (Retinal vessel analyzer) [measurements done only once on the studyday]

  3. Optic nerve head blood flow (laser Doppler flowmetry) [measurements done only once on the studyday]

  4. Latency and amplitude (pattern ERG) [measurements done only once on the studyday]

Secondary Outcome Measures

  1. Mean arterial pressure [measurements done only once on the studyday]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men and women aged between 20 and 80 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 open angle glaucoma.

  • 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:
  • Treatment with vasoactive drugs.

  • Presence of intraocular pathology other than open angle glaucoma.

  • Presence of ocular hypertension or PEX (pseudoexfoliation) glaucoma

  • History or family history of epilepsy.

  • Pregnancy.

  • Diabetes mellitus.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Meical University of Vienna, Austria Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Gabriele Fuchsjäger Mayrl, MD, Department of Clinical Pharmacology, Meical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00811694
Other Study ID Numbers:
  • OPHT-200104
First Posted:
Dec 19, 2008
Last Update Posted:
Nov 21, 2014
Last Verified:
Nov 1, 2014
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2014