- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46202
- Department of Ophthalmology Indiana University School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
aqueous suppressant
aqueous suppressant treated
|
|
aqueous outflow
aqueous outflow treated
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
6-month Change in Ocular Perfusion Pressures (OPP)
Tidsramme: Baseline and 6 month visits
|
Baseline and 6 month visits
|
|
2-year Change in OA PSV
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OA EDV
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OA RI
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA PSV
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA EDV
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in CRA RI
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
|
2-year Change in OPP
Tidsramme: Baseline and 24 month visits
|
Baseline and 24 month visits
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Alon Harris, PhD, Indiana University School of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IGPS-prost-OAG
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .