Clincosm LogoSign in Get a demo

Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00707226
Collaborator
(none)
30
Enrollment
1
Location
13
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After focusing many years only on intraocular pressure (IOP) as the primary risk factor, recently the impact of ocular blood flow is getting more consideration for the pathophysiology of glaucoma. The circadian change of intraocular pressure (IOP) is well investigated, but diurnal variations in ocular blood flow are yet to be evaluated, especially in glaucomatous eyes.

This study is performed to investigate circadian variation of ocular blood flow assessed by laser interferometric fundus pulsation amplitude (FPA) and laser Doppler flowmetry (LDF) in glaucomatous eyes during topical antiglaucoma therapy at 8:00, 12:00, 17:00 and 21:00, to compare these circadian variation of ocular blood flow in glaucomatous eyes with variations in healthy eyes and to relate blood flow variations with IOP variations.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes
    Study Start Date :
    Nov 1, 2000
    Actual Study Completion Date :
    Dec 1, 2001

    Arms and Interventions

    Arm Intervention/Treatment
    1

    15 patients with primary open angle glaucoma
    2

    15 age matched healthy subjects

    Outcome Measures

    Primary Outcome Measures

    1. fundus pulsation amplitude choroidal blood flow IOP [13 hours]

    Secondary Outcome Measures

    1. blood pressure, pulse rate [13 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For the glaucoma patients:

    • Medical controlled Primary Open Angle Glaucoma with a history of more than 2 years

    • Topical medication with beta-blockers (timolol, betaxolol, levobunol)

    • IOP with medication < 22 mmHg (with a medical history of IOP > 22 mmHg)

    • Visual field testing: mild glaucomatous defects (Humphrey 30-2 with MD>10)

    • Optic nerve head: C/D-ratio between 0.4 and 0.9

    • ametropy < 3 dpt

    • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

    For the age matched control subjects:

    • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

    • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

    • Normal ophthalmic findings, ametropy < 3 dpt.

    Exclusion Criteria:
    For the glaucoma patients:

    • History of trabeculectomy or laser trabeculoplasty

    • Any other ocular disease with possible vascular involvement such as diabetic retinopathy, age related macular disease, retinal vein or artery occlusion.

    • Uncontrolled systemic hypertension (defined as systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg)

    • Diabetes mellitus

    For the age matched control subjects:

    • abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

    • Symptoms of a clinically relevant illness in the 3 weeks before the first study day

    • History or presence of gastrointestinal, liver or kidney disease

    • Ametropy > 3 dpt

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Michael Georgopoulos, MD, Department of Clinical Ophthalmology, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00707226
    Other Study ID Numbers:
    • OPHT-171000
    First Posted:
    Jun 30, 2008
    Last Update Posted:
    Jun 30, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Laser Doppler flowmetry
    Choroidal blood flow
    Fundus pulsation amplitude
    Intraocular Pressure
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Jun 30, 2008