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Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304264
First Posted: February 25, 2011
Last Update Posted: January 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Indiana University School of Medicine
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ingrida Januleviciene, Lithuanian University of Health Sciences
  Purpose
To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

Condition Intervention
Open Angle Glaucoma Device: Color Doppler Imaging

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy

Resource links provided by NLM:


Further study details as provided by Ingrida Januleviciene, Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • Ocular Color Doppler Imaging [ Time Frame: 8 AM; 8 PM ]

    Color Doppler Imaging

    • Nasal post ciliary artery (NPCA)
    • Temporal posterior ciliary artery (TPCA)
    • Ophthalmic artery (OA)
    • Central retinal artery (CRA)


Secondary Outcome Measures:
  • IOP, BP, OPP (mean, fluctuations, amplitude) [ Time Frame: 8 AM-12AM-4PM-8PM ]
    IOP, BP, OPP (mean, fluctuations, amplitude) Goldmann applanation tonometry Brachial artery pressure and radial pulse


Biospecimen Description:
No biospecimens will be retained

Enrollment: 35
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
combination topical glaucoma treatment
timolol or dorzolamide add on latanoprost monotherapy
Device: Color Doppler Imaging
Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).
Other Names:
  • timololum maleate
  • dorzolamidum
  • latanoprostum

Detailed Description:
Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Regular visitors of Eye Clinic of Lithuania University of Health Science hospital
Criteria

Inclusion Criteria:

  • Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

Exclusion Criteria:

  • younger than 18 years old
  • women of child bearing potential
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304264


Locations
Lithuania
Eye Clinic Lithuania Health Science Hospital Kaunas Clinics
Kaunas, Lithuania, 50009
Sponsors and Collaborators
Lithuanian University of Health Sciences
Indiana University School of Medicine
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ingrida Januleviciene, MD Lithuania University of Health Science
  More Information

Responsible Party: Ingrida Januleviciene, MD, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01304264     History of Changes
Other Study ID Numbers: 37552
First Submitted: February 24, 2011
First Posted: February 25, 2011
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Ingrida Januleviciene, Lithuanian University of Health Sciences:
glaucoma, ocular, blood flow, fluctuations

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases