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ISRCTN
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ISRCTN50904302
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ClinicalTrials.gov identifier
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Public title
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Ultrasound treatment for glaucoma
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Scientific title
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A randomised controlled prospective study of the effect of topical application of ultrasound for glaucoma
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Acronym
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TUG
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Serial number at source
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20091044
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Study hypothesis
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Low frequency ultrasound applied external to the limbus of the eye may induce a similar cytokine release to that of laser applied to the trabecular meshwork of the eye and thereby lead to a decrease in intra-ocular pressure.
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Ethics approval
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Western Institute Review Board approved on the 26th June 2009 (submission no.: e30817; study no.: 1109459; protocol ID: 20091044)
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Study design
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Randomised controlled prospective study
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Open angle glaucoma
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Participants - inclusion criteria
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1. Pre-existing glaucoma or ocular hypertension
2. Aged above 18 years, all genders welcome
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Participants - exclusion criteria
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Infants
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Anticipated start date
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20/08/2009
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Anticipated end date
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30/08/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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25
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Interventions
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Low frequency ultrasound application externally to the area adjacent to the limbus of the eye. Control is the other eye, where glaucoma is essentially equal - a coin toss determines which is the treated eye. The treatment is one session of approximately 10 minutes. The follow-up is for six months.
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Primary outcome measure(s)
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Intraocular pressure changes, measured at one day, one week, one month, two months, three months and six months.
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Secondary outcome measure(s)
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Tolerability to the intervention, measured at one day, one week, one month, two months, three months and six months.
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Sources of funding
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Eye Sonix (USA)
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Trial website
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Publications
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Contact name
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Dr
Donald
Schwartz
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Address
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2650 Elm Avenue #108
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City/town
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Long Beach
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Zip/Postcode
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90806
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Country
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United States of America
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Email
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dschwartz@eyesonix.com
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Sponsor
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Eye Sonix (USA)
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Address
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2650 Elm Avenue #108
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City/town
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Long Beach
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Zip/Postcode
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90806
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Country
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United States of America
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Email
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dschwartz@eyesonix.com
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Sponsor website:
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http://eyesonix.com/
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Date applied
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04/11/2009
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Last edited
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02/12/2009
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Date ISRCTN assigned
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02/12/2009
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