- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01308788
Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow
Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The purpose of this study will be to compare the aqueous production suppressant to aqueous outflow drugs in terms of the response to known vascular parameters. Specifically; systemic perfusion pressure, retrobulbar blood flow and retinal microcirculation.
A comparison of perfusion pressure, retinal microcirculation utilizing Heidelberg Retinal Flowmetry and retrobulbar circulation utilizing color Doppler ultrasound imaging
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Department of Ophthalmology Indiana University School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patients will meet all of the following inclusion criteria to enter the study:
- Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
- glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
- glaucomatous optic disc cupping
- agreement between two baseline exams for reliability
- Best corrected visual acuity at least 20/60 in at least one eye.
- Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).
Exclusion Criteria:
- Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
- Evidence of exfoliation or pigment dispersion.
- History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- History or signs of intraocular trauma.
- Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
- Any abnormality preventing reliable applanation tonometry.
- Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- Cataract surgery within the past year.
- Resting pulse < 50 beats per minute.
- Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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aqueous suppressant
aqueous suppressant treated
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aqueous outflow
aqueous outflow treated
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Délai: Baseline and 6 month visits
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Baseline and 6 month visits
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6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Délai: Baseline and 6 month visits
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Baseline and 6 month visits
|
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6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Délai: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Délai: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Délai: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Délai: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Ocular Perfusion Pressures (OPP)
Délai: Baseline and 6 month visits
|
Baseline and 6 month visits
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2-year Change in OA PSV
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
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2-year Change in OA EDV
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
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2-year Change in OA RI
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
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2-year Change in CRA PSV
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA EDV
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA RI
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
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2-year Change in OPP
Délai: Baseline and 24 month visits
|
Baseline and 24 month visits
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alon Harris, PhD, Indiana University School of Medicine
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
- IGPS-prost-OAG
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