Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
Information source: Indiana University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Phase: N/A
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Alon Harris, PhD, Principal Investigator, Affiliation: Indiana University School of Medicine
Overall contact:
Alon Harris, PhD, Phone: 317-278-0177, Email: alharris@indiana.edu
Summary
To analyze CosoptŪ in terms of its effects on ocular perfusion pressure and comprehensive
ocular blood flow and in relation to visual field progression and optic nerve structural
changes in an ongoing 3 year prospective study involving 120 patients with open angle
glaucoma.
Clinical Details
Official title: Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
Study design: Observational Model: Cohort, Time Perspective: Prospective
Detailed description:
To analyze CosoptŪ in terms of its effects on ocular perfusion pressure and comprehensive
ocular blood flow and in relation to visual field progression and optic nerve structural
changes in an ongoing 3 year prospective study involving 120 patients with open angle
glaucoma.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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.
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.
Locations and Contacts
Alon Harris, PhD, Phone: 317-278-0177, Email: alharris@indiana.edu
Indiana University School of Medicine, Department of Ophthalmology, Indianapolis, Indiana 46202, United States; Recruiting
Alon Harris, PhD, Phone: 317-278-0177, Email: alharris@indiana.edu
Brent Siesky, PhD, Phone: 317-278-0177, Email: bsiesky@indiana.edu
Alon Harris, PhD, Principal Investigator
Additional Information
Starting date: June 2010
Last updated: June 16, 2010
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