Ultrasound treatment for glaucoma
| ISRCTN | ISRCTN50904302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50904302 |
| Protocol serial number | 20091044 |
| Sponsor | Eye Sonix (USA) |
| Funder | Eye Sonix (USA) |
- 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
Scientific
2650 Elm Avenue #108
Long Beach
90806
United States of America
| dschwartz@eyesonix.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled prospective study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Intraocular pressure changes, measured at one day, one week, one month, two months, three months and six months. |
| Key secondary outcome measure(s) |
Tolerability to the intervention, measured at one day, one week, one month, two months, three months and six months. |
| Completion date | 30/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
90806
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
