Condition category
Eye Diseases
Date applied
04/11/2009
Date assigned
02/12/2009
Last edited
02/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://eyesonix.com/

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

Publication citations

Additional files

Editorial Notes