A randomized prospective study investigating the optimum power settings for selective laser trabeculoplasty (SLT) in ocular hypertension (OHT) and primary open angle glaucoma (POAG)
| ISRCTN | ISRCTN66330584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66330584 |
| Secondary identifying numbers | N0013184505 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 07/12/2010
- 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
Mr Avinash A Kulkarni
Scientific
Scientific
Lambeth Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)2071887188 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | At the present time, although SLT is accepted as a viable treatment for OHT / POAG, there has not been a thorough assessment of the optimum Laser power settings which enable safe and effective treatment. This study aims to scientifically compare high power settings with low power settings, investigating the efficacy of treatment in lowering intraocular pressure during the follow-up period after treatment, and the incidence of adverse events related to Laser treatment. Secondary Research Objectives: None |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Ocular hypertension (OHT) |
| Intervention | Research participants are to be recruited from the NHS glaucoma clinic at St. Thomas' Hospital over a 6 months period, starting 1st May 2004. Eligible participants will be patients with OHT or POAG, which is uncontrolled in one or both eyes despite maximal topical medical therapy. We aim to recruit 60 patients. Each patient will be randomized to treatment with the Laserex Solo SLT Glaucoma Laser in one of three treatment groups: Group 1 will receive high-energy SLT (1.2mJ shots) in one or both eyes Group 2 will receive medium energy SLT (0.8mJ shots) in one or both eyes Group 3 will receive low-energy SLT (0.4mJ shots) in one or both eyes. The decision to treat either one or both eyes will depend on whether the intraocular pressure is too high in one or both eyes. Therefore only eyes with uncontrolled pressure will be treated. Some patients may have both eyes treated. In these cases data for the study will only be collected for one eye. Thus, in total, 20 patients will be allocated to each of the 3 groups with 20 eyes per group (one per patient). |
| Intervention type | Other |
| Primary outcome measure | 1. Visual field defect progression 2. Disc cup appearances |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2005 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | Patients with OHT or POAG, which is uncontrolled despite maximal topical medical therapy. |
| Key exclusion criteria | Patients who do not meet inclusion criteria |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lambeth Road
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust
No information available
Own account
No information available
NHS R&D Support Funding
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 | 01/11/2010 | Yes | No |
