Skip to main content
OpenTrials
Completed

NCT Number: NCT01308788

Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this 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.

A comparison of perfusion pressure, retinal microcirculation utilizing Heidelberg Retinal Flowmetry and retrobulbar circulation utilizing color Doppler ultrasound imaging

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Age: 30 years or older.
  • Diagnosis: confirmed open-angle glaucoma in at least one eye:
  • glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
  • glaucomatous optic disc cupping
  • agreement between two baseline exams for reliability
  • Best corrected visual acuity at least 20/60 in at least one eye.
  • Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

    Time frame: Baseline and 6 month visits

  2. 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)

    Time frame: Baseline and 6 month visits

  3. 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)

    Time frame: Baseline and 6 month visits

  4. 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

    Time frame: Baseline and 6 month visits

  5. 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)

    Time frame: Baseline and 6 month visits

  6. 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)

    Time frame: Baseline and 6 month visits

  7. 6-month Change in Ocular Perfusion Pressures (OPP)

    Time frame: Baseline and 6 month visits

  8. 2-year Change in OA PSV

    Time frame: Baseline and 24 month visits

  9. 2-year Change in OA EDV

    Time frame: Baseline and 24 month visits

  10. 2-year Change in OA RI

    Time frame: Baseline and 24 month visits

  11. 2-year Change in CRA PSV

    Time frame: Baseline and 24 month visits

  12. 2-year Change in CRA EDV

    Time frame: Baseline and 24 month visits

  13. 2-year Change in CRA RI

    Time frame: Baseline and 24 month visits

  14. 2-year Change in OPP

    Time frame: Baseline and 24 month visits

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2011
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.