The Study of Ocular Hemodynamics With Glaucoma Progression (IGPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01145911
First received: June 15, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of Ocular Hemodynamics With Glaucoma Progression

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Ocular Blood Flow [ Time Frame: various ] [ Designated as safety issue: No ]
    per visit


Estimated Enrollment: 123
Study Start Date: February 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma patients
Glaucoma patients

Detailed Description:
  1. To determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis.
  2. To determine how changes in ocular blood flow are related to visual field progression.
  3. To determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.
  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

Glaucoma 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145911

Locations
United States, Indiana
Indiana University School of Medicine, Department of Ophthalmology
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: NCT01145911     History of Changes
Other Study ID Numbers: IGPS
Study First Received: June 15, 2010
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Glaucoma
Blood Flow
Progression

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014