Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Indiana University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Indiana University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01145898
First received: June 15, 2010
Last updated: February 16, 2011
Last verified: June 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To analyze Cosopt® 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.
| Condition |
|---|
|
Glaucoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Indiana University:
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Glaucoma patients
Patients with Glaucoma
|
Detailed Description:
To analyze Cosopt® 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| 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:
- Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
- glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
- glaucomatous optic disc cupping
- agreement between two baseline exams for reliability
- Best corrected visual acuity at least 20/60 in at least one eye.
- Prior Humphrey visual fields demonstrate acceptable reliability standards.
Exclusion Criteria:
- Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
- Evidence of exfoliation or pigment dispersion.
- History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- History or signs of intraocular trauma.
- Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
- Any abnormality preventing reliable applanation tonometry.
- Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- Cataract surgery within the past year.
- Resting pulse < 50 beats per minute.
- Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145898
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: | Alon Harris, Professor of Ophthalmology, Letzter Endowed Chair in Ophthalmology, Director of Clinical Research, Eugene and Marilyn Glick Eye Institute, Professor of Cellular & Integrative Physiology, Indiana University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01145898 History of Changes |
| Other Study ID Numbers: | Cosopt and OAG progression |
| Study First Received: | June 15, 2010 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Glaucoma Cosopt blood flow progression |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Dorzolamide Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013