Neurovascular Coupling in Patients With Open Angle Glaucoma

NCT00811694 | Terminated DMC

• 1 other identifier: OPHT-200104
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; ficker stimulation; ocular blood flow

Outcome Measures

Primary Outcomes (4)

• Retinal blood velocity (laser Doppler velocimetry)

  measurements done only once on the studyday

• Retinal arterial and venous diameter (Retinal vessel analyzer)

  measurements done only once on the studyday

• Optic nerve head blood flow (laser Doppler flowmetry)

  measurements done only once on the studyday

• Latency and amplitude (pattern ERG)

  measurements done only once on the studyday

Secondary Outcomes (1)

• Mean arterial pressure

  measurements done only once on the studyday

Study Arms (2)

a

15 male and 15 female patients with glaucoma

Other: ocular blood flow measurements

b

30 sex matched healthy volunteers

Other: ocular blood flow measurements

Interventions

ocular blood flow measurements OTHER

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

a; b

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Meical University of Vienna, Austria

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Gabriele Fuchsjäger Mayrl, MD

  Department of Clinical Pharmacology, Meical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: December 19, 2008
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2012
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

AU (1)