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
Protocol serial number	N0013184505
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust, Own account, NHS R&D Support Funding

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

Lambeth Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)2071887188

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Visual field defect progression 2. Disc cup appearances
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Lambeth Road

London
SE1 7EH
United Kingdom

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	01/11/2010		Yes	No