- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00811694
Neurovascular Coupling in Patients With Open Angle Glaucoma
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Vienna, Oostenrijk, 1090
- Department of Clinical Pharmacology, Meical University of Vienna, Austria
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
a
15 male and 15 female patients with glaucoma
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non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
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b
30 sex matched healthy volunteers
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non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Retinal blood velocity (laser Doppler velocimetry)
Tijdsspanne: measurements done only once on the studyday
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measurements done only once on the studyday
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Retinal arterial and venous diameter (Retinal vessel analyzer)
Tijdsspanne: measurements done only once on the studyday
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measurements done only once on the studyday
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Optic nerve head blood flow (laser Doppler flowmetry)
Tijdsspanne: measurements done only once on the studyday
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measurements done only once on the studyday
|
|
Latency and amplitude (pattern ERG)
Tijdsspanne: measurements done only once on the studyday
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measurements done only once on the studyday
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Mean arterial pressure
Tijdsspanne: measurements done only once on the studyday
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measurements done only once on the studyday
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gabriele Fuchsjäger Mayrl, MD, Department of Clinical Pharmacology, Meical University of Vienna
Studie record data
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Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OPHT-200104
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