Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Glaucoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
aqueous suppressant
aqueous suppressant treated
|
|
aqueous outflow
aqueous outflow treated
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
120 glacuoma patients
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.
Contacts and Locations| United States, Indiana | |
| Department of Ophthalmology Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Alon Harris, PhD | Indiana University School of Medicine |
More Information
No publications provided
| Responsible Party: | Alon Harris, PhD, MS Director of Clinical Research, Lois Letzter Professor of Ophthalmology, Department of Ophthalmology Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01308788 History of Changes |
| Other Study ID Numbers: | IGPS-prost-OAG |
| Study First Received: | March 2, 2011 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
glaucoma blood flow |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013