Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308788
• Other study ID #: IGPS-prost-OAG
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: January 23, 2014
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
United States	Department of Ophthalmology Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)		Baseline and 6 month visits	No
Primary	6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)		Baseline and 6 month visits	No
Primary	6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)		Baseline and 6 month visits	No
Primary	6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)		Baseline and 6 month visits	No
Primary	6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)		Baseline and 6 month visits	No
Primary	6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)		Baseline and 6 month visits	No
Primary	6-month Change in Ocular Perfusion Pressures (OPP)		Baseline and 6 month visits	No
Primary	2-year Change in OA PSV		Baseline and 24 month visits	No
Primary	2-year Change in OA EDV		Baseline and 24 month visits	No
Primary	2-year Change in OA RI		Baseline and 24 month visits	No
Primary	2-year Change in CRA PSV		Baseline and 24 month visits	No
Primary	2-year Change in CRA EDV		Baseline and 24 month visits	No
Primary	2-year Change in CRA RI		Baseline and 24 month visits	No
Primary	2-year Change in OPP		Baseline and 24 month visits	No