Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01308788
First received: March 2, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 6-month Change in Ocular Perfusion Pressures (OPP) [ Time Frame: Baseline and 6 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in OA PSV [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in OA EDV [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in OA RI [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in CRA PSV [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in CRA EDV [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in CRA RI [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]
  • 2-year Change in OPP [ Time Frame: Baseline and 24 month visits ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
aqueous suppressant
aqueous suppressant treated
aqueous outflow
aqueous outflow treated

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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

120 glacuoma patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308788

Locations
United States, Indiana
Department of Ophthalmology Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Alon Harris, PhD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01308788     History of Changes
Other Study ID Numbers: IGPS-prost-OAG
Study First Received: March 2, 2011
Results First Received: September 20, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
glaucoma blood flow

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014