The Study of Ocular Hemodynamics With Glaucoma Progression (IGPS)

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

Study Overview

• Status: Completed
• Conditions: Glaucoma

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.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Glaucoma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Blood Flow	per visit	various

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Alon Harris, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 3, 2014
• Study Completion (Actual): July 3, 2014

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Progression; Glaucoma; Blood Flow
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Ocular Hypertension; Glaucoma; Disease Progression
• Other Study ID Numbers: IGPS