Ultrasound treatment for glaucoma

ISRCTN	ISRCTN50904302
DOI	https://doi.org/10.1186/ISRCTN50904302
Secondary identifying numbers	20091044

Submission date: 04/11/2009
Registration date: 02/12/2009
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Donald Schwartz
Scientific

2650 Elm Avenue #108
Long Beach
90806
United States of America

Email	dschwartz@eyesonix.com

Study information

Study design	Randomised controlled prospective study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled prospective study of the effect of topical application of ultrasound for glaucoma
Study acronym	TUG
Study objectives	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(s)	Western Institute Review Board approved on the 26th June 2009 (submission no.: e30817; study no.: 1109459; protocol ID: 20091044)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/08/2009
Completion date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	25
Total final enrolment	26
Key inclusion criteria	1. Pre-existing glaucoma or ocular hypertension 2. Aged above 18 years, all genders welcome
Key exclusion criteria	Infants
Date of first enrolment	20/08/2009
Date of final enrolment	30/08/2010

Locations

Countries of recruitment

United States of America

Study participating centre

2650 Elm Avenue #108

Long Beach
90806
United States of America

Sponsor information

Eye Sonix (USA)
Industry

2650 Elm Avenue #108
Long Beach
90806
United States of America

Email	dschwartz@eyesonix.com
Website	http://eyesonix.com/
"ROR"	https://ror.org/04qqvvm35

Funders

Funder type

Industry

Eye Sonix (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/09/2014	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.