- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Department of Ophthalmology Indiana University School of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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aqueous suppressant
aqueous suppressant treated
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aqueous outflow
aqueous outflow treated
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
6-month Change in Ocular Perfusion Pressures (OPP)
Tidsram: Baseline and 6 month visits
|
Baseline and 6 month visits
|
2-year Change in OA PSV
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OA EDV
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OA RI
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA PSV
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA EDV
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in CRA RI
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
2-year Change in OPP
Tidsram: Baseline and 24 month visits
|
Baseline and 24 month visits
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alon Harris, PhD, Indiana University School of Medicine
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
- IGPS-prost-OAG
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