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

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ClinicalTrials.gov Identifier: NCT01304264
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : January 12, 2012
Sponsor:
Collaborators:
Indiana University School of Medicine
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ingrida Januleviciene, Lithuanian University of Health Sciences

Brief Summary:
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 or disease Intervention/treatment
Open Angle Glaucoma Device: Color Doppler Imaging

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

Study Type : Observational
Actual Enrollment : 35 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Ingrida Januleviciene, MD, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01304264     History of Changes
Other Study ID Numbers: 37552
First Posted: February 25, 2011    Key Record Dates
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