Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013184505
Study information
Scientific title
Acronym
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Visual field defect progression
2. Disc cup appearances
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2005
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with OHT or POAG, which is uncontrolled despite maximal topical medical therapy.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Patients who do not meet inclusion criteria
Recruitment start date
01/08/2005
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lambeth Road
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20472748
Publication citations
-
Results
Goyal S, Beltran-Agullo L, Rashid S, Shah SP, Nath R, Obi A, Lim KS, Effect of primary selective laser trabeculoplasty on tonographic outflow facility: a randomised clinical trial., Br J Ophthalmol, 2010, 94, 11, 1443-1447, doi: 10.1136/bjo.2009.176024.