Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

NCT ID: NCT01308788

Last Updated: 2014-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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

Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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aqueous suppressant

aqueous suppressant treated

No interventions assigned to this group

aqueous outflow

aqueous outflow treated

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alon Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Department of Ophthalmology Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IGPS-prost-OAG

Identifier Type: -

Identifier Source: org_study_id

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