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

This study has been completed.
Sponsor:
Collaborators:
Indiana University School of Medicine
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ingrida Januleviciene, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01304264
First received: February 24, 2011
Last updated: January 11, 2012
Last verified: January 2012
  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 Lithuanian University of Health Sciences:

Primary Outcome Measures:
  • Ocular Color Doppler Imaging [ Time Frame: 8 AM; 8 PM ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ingrida Januleviciene, MD, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT01304264     History of Changes
Other Study ID Numbers: 37552
Study First Received: February 24, 2011
Last Updated: January 11, 2012
Health Authority: Lithuania: Bioethics Committee

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

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

ClinicalTrials.gov processed this record on November 23, 2014