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

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  • معلومة اضافية
    • Corporate Authors:
      LiGHT Trial Study Group
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
      Laser Therapy*/adverse effects ; Laser Therapy*/methods ; Laser Therapy*/statistics & numerical data ; Trabeculectomy*/adverse effects ; Trabeculectomy*/methods ; Trabeculectomy*/statistics & numerical data; Antihypertensive Agents/*administration & dosage ; Glaucoma, Open-Angle/*therapy ; Ocular Hypertension/*therapy; Administration, Ophthalmic ; Antihypertensive Agents/adverse effects ; Clinical Protocols ; Combined Modality Therapy ; Data Interpretation, Statistical ; Drug Administration Schedule ; Glaucoma, Open-Angle/diagnosis ; Glaucoma, Open-Angle/physiopathology ; Humans ; Models, Statistical ; Ocular Hypertension/diagnosis ; Ocular Hypertension/physiopathology ; Ophthalmic Solutions ; Quality of Life ; Research Design ; Time Factors ; Treatment Outcome ; United Kingdom
    • نبذة مختصرة :
      Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). 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 patients (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 Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient 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 .
    • Comments:
      Erratum in: Trials. 2017 Jul 11;18(1):318. doi: 10.1186/s13063-017-2033-1. (PMID: 28697781)
    • References:
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    • Grant Information:
      09/104/40 United Kingdom DH_ Department of Health; II-LA-0813-20004 United Kingdom DH_ Department of Health
    • Contributed Indexing:
      Investigator: G Gazzard; S Wilson; D Broadway; S Lim; R Bourne; T Manners; N Strouthidis; K Barton; R Wormald; S Morris; R Hunter; G Rubin; D Garway-Heath; M Buszewicz; G Ambler; C Bunce; V Vickerstaff; A Davis; N Nathwani; E Konstantakopoulou; H Zhou; Y Jiang
    • Molecular Sequence:
      ISRCTN ISRCTN32038223
    • الرقم المعرف:
      0 (Antihypertensive Agents)
      0 (Ophthalmic Solutions)
    • الموضوع:
      Date Created: 20151113 Date Completed: 20160711 Latest Revision: 20210109
    • الموضوع:
      20250114
    • الرقم المعرف:
      PMC4642765
    • الرقم المعرف:
      10.1186/s13063-015-1047-9
    • الرقم المعرف:
      26559142