The Study of Ocular Hemodynamics With Glaucoma Progression

Glaucoma Clinical Trial

— IGPS  

Official title:

The Study of Ocular Hemodynamics With Glaucoma Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145911
• Other study ID #: IGPS
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: March 6, 2017
• Start date: January 2008
• Est. completion date: July 3, 2014

Study information

• Verified date: March 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 3, 2014
• Est. primary completion date: July 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Glaucoma

Locations

Country	Name	City	State
United States	Indiana University School of Medicine, Department of Ophthalmology	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Blood Flow	per visit	various