- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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-
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Vienna, L'Autriche, 1090
- Department of Clinical Pharmacology, Meical University of Vienna, Austria
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
a
15 male and 15 female patients with glaucoma
|
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Retinal blood velocity (laser Doppler velocimetry)
Délai: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Retinal arterial and venous diameter (Retinal vessel analyzer)
Délai: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Optic nerve head blood flow (laser Doppler flowmetry)
Délai: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Latency and amplitude (pattern ERG)
Délai: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Mean arterial pressure
Délai: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gabriele Fuchsjäger Mayrl, MD, Department of Clinical Pharmacology, Meical University of Vienna
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OPHT-200104
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