Statistical analysis plan for the Laser-1st versus Drops-1st for XXXX Trial (LiGHT): a multi-centre randomised controlled trial.

@entity1 @entity2790 @entity1538 @entity726
BACKGROUND: The LiGHT trial (Laser-1st versus Drops-1st for @entity2790 Trial) is a multicentre randomised controlled trial of two treatment pathways for @entity1 who are newly diagnosed with @entity1538 ( @entity1538 ) and @entity2790 ( @entity2790 ). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study. METHODS/DESIGN: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 @entity1 (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36  months. The primary outcome measure is health-related quality of life (HRQL) at 36  months measured using the EQ-5D-5L. The main secondary outcome is the @entity726 Index. We plan to analyse the @entity1 outcome data according to the group to which the @entity1 was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses. TRIAL REGISTRATION: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 .
