Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

Completed

• Conditions: Glaucoma

• Registration Number: NCT01308788
• Lead Sponsor: Indiana University

Brief 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.

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

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-09-20
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-23
• Last Update Submitted: 2014-01-23
• Results First Posted: 2014-01-27
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients will meet all of the following inclusion criteria to enter the study:

1. Age: 30 years or older.

2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

   1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
   2. glaucomatous optic disc cupping
   3. agreement between two baseline exams for reliability

3. Best corrected visual acuity at least 20/60 in at least one eye.

4. Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Exclusion Criteria

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse < 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)	Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)	Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)	Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)	Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)	Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)	Baseline and 6 month visits
6-month Change in Ocular Perfusion Pressures (OPP)	Baseline and 6 month visits
2-year Change in OA PSV	Baseline and 24 month visits
2-year Change in OA EDV	Baseline and 24 month visits
2-year Change in OA RI	Baseline and 24 month visits
2-year Change in CRA PSV	Baseline and 24 month visits
2-year Change in CRA EDV	Baseline and 24 month visits
2-year Change in CRA RI	Baseline and 24 month visits
2-year Change in OPP	Baseline and 24 month visits

Trial Locations

Locations (1)

Department of Ophthalmology Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States