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ISRCTN
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ISRCTN66330584
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ClinicalTrials.gov identifier
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Public title
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A randomized prospective study investigating the optimum power settings for selective laser trabeculoplasty (SLT) in ocular hypertension (OHT) and primary open angle glaucoma (POAG)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013184505
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Study hypothesis
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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
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Eye Diseases: Ocular hypertension (OHT)
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Participants - inclusion criteria
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Patients with OHT or POAG, which is uncontrolled despite maximal topical medical therapy.
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Participants - exclusion criteria
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Patients who do not meet inclusion criteria.
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Anticipated start date
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01/08/2005
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Anticipated end date
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01/08/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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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).
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Primary outcome measure(s)
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1. Visual field defect progression
2. Disc cup appearances
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Avinash A.
Kulkarni
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Address
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Lambeth Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 02071887188
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Fax
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+44
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Email
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avi@orange.net
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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05/11/2007
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Date ISRCTN assigned
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28/09/2007
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