- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
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Vienna, Österrike, 1090
- Department of Clinical Pharmacology, Meical University of Vienna, Austria
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Retinal blood velocity (laser Doppler velocimetry)
Tidsram: measurements done only once on the studyday
|
measurements done only once on the studyday
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Retinal arterial and venous diameter (Retinal vessel analyzer)
Tidsram: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Optic nerve head blood flow (laser Doppler flowmetry)
Tidsram: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Latency and amplitude (pattern ERG)
Tidsram: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Mean arterial pressure
Tidsram: measurements done only once on the studyday
|
measurements done only once on the studyday
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gabriele Fuchsjäger Mayrl, MD, Department of Clinical Pharmacology, Meical University of Vienna
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OPHT-200104
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