N/A
N=35
Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01308788 ↗Enrolled (actual)
35
Serious AEs
—
Results posted
Jan 2014
Primary outcome: Primary: 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) — -.70; 1.84 cm/sec — p=.4414
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) |
-.70; 1.84 | .4414 |
| PRIMARY 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV) |
-.36; .12 | .7820 |
| PRIMARY 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI) |
.003; .014 | .5496 |
| PRIMARY 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) |
-.16; .09 | .2930 |
| PRIMARY 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) |
-.13; -.03 | .5058 |
| PRIMARY 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) |
.029; .005 | .6156 |
| PRIMARY 6-month Change in Ocular Perfusion Pressures (OPP) |
-3.38; -.63 | .5443 |
| PRIMARY 2-year Change in OA PSV |
1.39; 2.63 | .7847 |
| PRIMARY 2-year Change in OA EDV |
-1.28; .34 | .1331 |
| PRIMARY 2-year Change in OA RI |
.035; .019 | .5431 |
| PRIMARY 2-year Change in CRA PSV |
1.46; .19 | .0684 |
| PRIMARY 2-year Change in CRA EDV |
.43; .16 | .2500 |
| PRIMARY 2-year Change in CRA RI |
.005; -.010 | .6896 |
| PRIMARY 2-year Change in OPP |
-1.26; -3.02 | .7965 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01308788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.