Neurovascular Coupling in Patients With Open Angle Glaucoma

Glaucoma Clinical Trial

Official title:

Neurovascular Coupling in Patients With Open Angle Glaucoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00811694
• Other study ID #: OPHT-200104
• Status: Terminated
• Phase: N/A
• First received: July 2, 2008
• Last updated: November 20, 2014
• Start date: October 2006
• Est. completion date: May 2012

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Meical University of Vienna, Austria	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal blood velocity (laser Doppler velocimetry)		measurements done only once on the studyday	No
Primary	Retinal arterial and venous diameter (Retinal vessel analyzer)		measurements done only once on the studyday	No
Primary	Optic nerve head blood flow (laser Doppler flowmetry)		measurements done only once on the studyday	No
Primary	Latency and amplitude (pattern ERG)		measurements done only once on the studyday	No
Secondary	Mean arterial pressure		measurements done only once on the studyday	No