| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN66330584 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0013184505 |
| Public title | A randomized prospective study investigating the optimum power settings for selective laser trabeculoplasty (SLT) in ocular hypertension (OHT) and primary open angle glaucoma (POAG) |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Ocular hypertension (OHT) |
| Study hypothesis | 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with OHT or POAG, which is uncontrolled despite maximal topical medical therapy. |
| Participants - exclusion criteria | Patients who do not meet inclusion criteria. |
| Patient information material |
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| Anticipated start date | 01/08/2005 |
| Anticipated end date | 01/08/2006 |
| Status of trial | Completed |
| Target number of participants | 40 |
| Interventions | 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). |
| Primary outcome measure(s) | 1. Visual field defect progression
2. Disc cup appearances |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Avinash A. Kulkarni |
| Contact details | Lambeth Road
London
United Kingdom
SE1 7EH |
| Contact telephone | +44 02071887188 |
| Contact fax | +44 |
| Contact email | avi@orange.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66330584 |
| Date last extracted from ISRCTN register | 17/04/2008 |
