- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Vienna, Austria, 1090
- Department of Clinical Pharmacology, Meical University of Vienna, Austria
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Retinal blood velocity (laser Doppler velocimetry)
Periodo de tiempo: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Retinal arterial and venous diameter (Retinal vessel analyzer)
Periodo de tiempo: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Optic nerve head blood flow (laser Doppler flowmetry)
Periodo de tiempo: measurements done only once on the studyday
|
measurements done only once on the studyday
|
|
Latency and amplitude (pattern ERG)
Periodo de tiempo: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Mean arterial pressure
Periodo de tiempo: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gabriele Fuchsjäger Mayrl, MD, Department of Clinical Pharmacology, Meical University of Vienna
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OPHT-200104
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