The Study of Ocular Hemodynamics With Glaucoma Progression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01145911

Acronym

IGPS

Enrollment

123

Registered

2010-06-17

Start date

2008-01-31

Completion date

2014-07-03

Last updated

2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, Blood Flow, Progression

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ocular Blood Flow	various	per visit

Countries

United States

Outcome results