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
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01145898
First received: June 15, 2010
Last updated: February 16, 2011
Last verified: June 2010
  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:


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:

  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.
  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