- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Indiana
-
Indianapolis, Indiana, Vereinigte Staaten, 46202
- Department of Ophthalmology Indiana University School of Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
aqueous suppressant
aqueous suppressant treated
|
|
aqueous outflow
aqueous outflow treated
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Ocular Perfusion Pressures (OPP)
Zeitfenster: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
2-year Change in OA PSV
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OA EDV
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OA RI
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA PSV
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA EDV
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA RI
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OPP
Zeitfenster: Baseline and 24 month visits
|
Baseline and 24 month visits
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Alon Harris, PhD, Indiana University School of Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IGPS-prost-OAG
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .