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The laser in glaucoma and ocular hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics
  1. Evgenia Konstantakopoulou1,2,
  2. Gus Gazzard1,2,
  3. Victoria Vickerstaff3,4,
  4. Yuzhen Jiang1,2,
  5. Neil Nathwani1,
  6. Rachael Hunter5,
  7. Gareth Ambler6,
  8. Catey Bunce1,7,8
  9. on behalf of the LiGHT Trial Study Group
    1. 1 NIHR Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK
    2. 2 Institute of Ophthalmology, University College London, London, UK
    3. 3 Marie Curie Palliative Care Research Department, UCL Division of Psychiatry, University College London, London, UK
    4. 4 The Research Department of Primary Care and Population Health, University College London, London, UK
    5. 5 Priment Clinical Trials Unit, University College London, Royal Free Medical School, London, UK
    6. 6 Department of Statistical Science, University College London, London, UK
    7. 7 Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK
    8. 8 Department of Primary Care and Public Health, Kings College London, London, UK
    1. Correspondence to Gus Gazzard, NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, 162 City Road, London EC1V 2PD, UK; gusgazzard{at}gmail.com

    Abstract

    Purpose The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT).

    Design LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT).

    Participants 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014.

    Methods Patients were randomised to initial SLT followed by medical therapy or medical therapy without laser. Participants will be monitored for 3 years, according to routine clinical practice. The primary outcome is EQ-5D-5L. Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index (GUI), Glaucoma Symptom Scale, Glaucoma Quality of Life (GQL), pathway effectiveness, visual function, safety and concordance.

    Results A total of 555 patients had POAG and 163 OHT; 518 patients had both eyes eligible. The mean age for patients with POAG was 64 years and for OHT 58 years. 70% of all participants were white. Median IOP for OHT eyes was 26 mm Hg and 23 mm Hg for POAG eyes. Median baseline visual field mean deviation was −0.81 dB for OHT eyes and −2.82 dB for POAG eyes. There was no difference between patients with POAG and patients with OHT on the EQ-5D-5DL; the difference between OHT and POAG on the GUI was −0.02 and 1.23 on the GQL.

    Conclusions The LiGHT trial is the first RCT to compare the two treatment options in a real-world setting. The baseline characteristics of the LiGHT cohort compare well with other landmark glaucoma studies.

    Trial registration number ISRCTN32038223, Pre-results.

    • Glaucoma
    • Intraocular Pressure
    • Treatment Lasers

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    Footnotes

    • Contributors EK wrote the manuscript together with GG and is involved in the acquisition of the data. YJ contributed to the drafting of the paper. VV was involved in the analysis of the data. NN contributed to the drafting of the paper and is involved in the acquisition of the data. RH, GA and CB contributed to the design of the outcome measures and the data to be collected and was involved in the drafting of the manuscript. GG led the initial conception and design of the trial and writing the protocol, acquired funding and ethics approval, is the chief investigator of the trial and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

    • Competing interests GG, RH, GA and CB have received a grant from the NIHR for the submitted work. GG has received a research grant from Lumenis prior to the submitted work.

    • Ethics approval The City Road and Hampstead Research and Ethics Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators The LiGHT Trial Study Group is Gareth Ambler, Keith Barton, Rupert Bourne, David Broadway, Catey Bunce, Marta Buszewicz, Amanda Davis, Anurag Garg, David Garway-Heath, Gus Gazzard, Rachael Hunter, Yuzhen Jiang, Evgenia Konstantakopoulou, Sheng Lim, Joanna Liput, Timothy Manners, Stephen Morris, Neil Nathwani, Gary Rubin, Nicholas Strouthidis, Victoria Vickerstaff, Sarah Wilson, Richard Wormald, Haogang Zhu.

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