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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Department of Ophthalmology Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

120 glacuoma patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
aqueous suppressant; aqueous suppressant treated
aqueous outflow; aqueous outflow treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Alon Harris, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 2, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2014
• Last Update Submitted That Met QC Criteria: January 23, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: glaucoma blood flow
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: IGPS-prost-OAG