Effects of Common Topical Glaucoma Therapy on Optic Nerve Head Blood Flow Autoregulation During Increased Arterial Blood Pressure and Artificially Elevated Intraocular Pressure in Healthy Humans
NCT ID: NCT00275756
Last Updated: 2014-11-21
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2008-09-30
2014-11-30
Brief Summary
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Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve circulation has been shown in animals and humans. The exact mechanism behind this autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH) blood flow autoregulation is to enhance the understanding of pathologic eye conditions associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH microcirculation is of critical importance to understand the pathophysiology of glaucoma, because there is evidence that glaucoma is associated with optic nerve head ischemia. Several studies indicate that a disturbed autoregulation might contribute to glaucomatous optic neuropathy. Currently, five classes of intraocular pressure (IOP) reducing drugs are available for topical therapy in patients with glaucoma or elevated intraocular pressure. These drugs have also vasoactive properties, which may influence both the resting ocular circulation and the autoregulatory mechanisms of blood flow during changes in ocular perfusion pressure.
Study objective
To investigate the influence of common topical glaucoma therapy on ONH blood flow regulation during changes in IOP and systemic arterial blood pressure.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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1
Timolol (drug)
Timolol (0.5%, non-selective beta-blocker, Timoptic®, Merck Sharp \& Dohme, Haarlem, Netherlands), dose 1 drop in one eye twice daily for two weeks
Laser Doppler flowmetry
blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
Goldmann applanation tonometer
intraocular pressure measurements, in total 2x 5 measurements on two study days
Suction cup method
The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
2
dorzolamide (drug)
Dorzolamide (2%, carbonic anhydrase inhibitor, Trusopt®, Laboratoires Merck Sharp \& Dohme - Chibret, France), dose: 1 drop in one eye twice daily for two weeks
Laser Doppler flowmetry
blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
Goldmann applanation tonometer
intraocular pressure measurements, in total 2x 5 measurements on two study days
Suction cup method
The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
3
brimonidine (drug)
Brimonidine (0.2%. alpha-2 adrenergic agonist, Alphagan®, Allergan Pharmaceuticals, Westport, Ireland), dose: 1 drop in one eye twice daily for two weeks
Laser Doppler flowmetry
blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
Goldmann applanation tonometer
intraocular pressure measurements, in total 2x 5 measurements on two study days
Suction cup method
The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
Interventions
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Timolol (drug)
Timolol (0.5%, non-selective beta-blocker, Timoptic®, Merck Sharp \& Dohme, Haarlem, Netherlands), dose 1 drop in one eye twice daily for two weeks
dorzolamide (drug)
Dorzolamide (2%, carbonic anhydrase inhibitor, Trusopt®, Laboratoires Merck Sharp \& Dohme - Chibret, France), dose: 1 drop in one eye twice daily for two weeks
brimonidine (drug)
Brimonidine (0.2%. alpha-2 adrenergic agonist, Alphagan®, Allergan Pharmaceuticals, Westport, Ireland), dose: 1 drop in one eye twice daily for two weeks
Laser Doppler flowmetry
blood flow measurements at the temporal neuroretinal rim of the optic nerve head, in total 4x 9 minutes on 2 study days
Goldmann applanation tonometer
intraocular pressure measurements, in total 2x 5 measurements on two study days
Suction cup method
The IOP will be raised by an 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus; 4x 8 minutes on 2 study days
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt.
Exclusion Criteria
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases
19 Years
35 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Department of Clinical Pharmacology, Medical University of Vienna
Principal Investigators
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Gabriele Fuchsjaeger-Mayrl, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology
Locations
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Department of Clinical Pharmacology
Vienna, , Austria
Countries
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Other Identifiers
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OPHT-040106
Identifier Type: -
Identifier Source: org_study_id