Contact information
Type
Scientific
Primary contact
Dr Donald Schwartz
ORCID ID
Contact details
2650 Elm Avenue #108
Long Beach
90806
United States of America
dschwartz@eyesonix.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20091044
Study information
Scientific title
A randomised controlled prospective study of the effect of topical application of ultrasound for glaucoma
Acronym
TUG
Study hypothesis
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.
Ethics approval
Western Institute Review Board approved on the 26th June 2009 (submission no.: e30817; study no.: 1109459; protocol ID: 20091044)
Study design
Randomised controlled prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Open angle glaucoma
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Intraocular pressure changes, measured at one day, one week, one month, two months, three months and six months.
Secondary outcome measures
Tolerability to the intervention, measured at one day, one week, one month, two months, three months and six months.
Overall trial start date
20/08/2009
Overall trial end date
30/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pre-existing glaucoma or ocular hypertension
2. Aged above 18 years, all genders welcome
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant exclusion criteria
Infants
Recruitment start date
20/08/2009
Recruitment end date
30/08/2010
Locations
Countries of recruitment
United States of America
Trial participating centre
2650 Elm Avenue #108
Long Beach
90806
United States of America
Sponsor information
Organisation
Eye Sonix (USA)
Sponsor details
2650 Elm Avenue #108
Long Beach
90806
United States of America
dschwartz@eyesonix.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Eye Sonix (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary