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

NCT ID: NCT01304264

Last Updated: 2012-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-11-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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combination topical glaucoma treatment

timolol or dorzolamide add on latanoprost monotherapy

Color Doppler Imaging

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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timololum maleate dorzolamidum latanoprostum

Eligibility Criteria

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Inclusion Criteria

* Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

Exclusion Criteria

* younger than 18 years old
* women of child bearing potential
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ingrida Januleviciene

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrida Januleviciene, MD

Role: PRINCIPAL_INVESTIGATOR

Lithuania University of Health Science

Locations

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Eye Clinic Lithuania Health Science Hospital Kaunas Clinics

Kaunas, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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37552

Identifier Type: -

Identifier Source: org_study_id

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