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  • Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: the glaucoma initial treatment study randomised clinical trial

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Clinical science
Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: the glaucoma initial treatment study randomised clinical trial
  1. Ghee Soon Ang1,
  2. Eva K Fenwick2,3,4,
  3. Marios Constantinou3,
  4. Alfred Tau Liang Gan2,
  5. Ryan Eyn Kidd Man2,
  6. Robert J Casson5,
  7. Eric A Finkelstein4,
  8. Ivan Goldberg6,
  9. Paul R Healey6,7,
  10. Konrad Pesudovs8,9,
  11. Sutha Sanmugasundram3,
  12. Jing Xie3,
  13. Rachel McIntosh3,
  14. Jonathan Jackson10,11,
  15. Anthony P Wells12,
  16. Andrew White6,7,13,
  17. Keith Martin1,3,14,15,
  18. Mark J Walland1,
  19. Jonathan G Crowston2,3,4,15,
  20. Ecosse Luc Lamoureux2,3,4
  1. 1 Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  2. 2 Singapore Eye Research Institute, Singapore National Eye Centre, Singapore
  3. 3 Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  4. 4 Duke-NUS Medical School, Singapore
  5. 5 Ophthalmology and Visual Sciences, South Australian Institute of Ophthalmology, University of Adelaide, Adelaide, South Australia, Australia
  6. 6 Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia
  7. 7 Westmead Institute for Medical Research, Sydney, New South Wales, Australia
  8. 8 School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
  9. 9 Vision and Eye Research Institute, Anglia Ruskin University, Cambridge, United Kingdom
  10. 10 National Vision Research Institute, Australian College of Optometry, Melbourne, Victoria, Australia
  11. 11 Royal Victoria Hospital (BHSCT), Belfast, Northern Ireland
  12. 12 Capital Eye Specialists, Wellington, New Zealand
  13. 13 Cambridge NIHR Biomedical Research Centre, University of Cambridge, Cambridge, UK
  14. 14 Ophthalmology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
  15. 15 Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Ecosse Luc Lamoureux, Ophthalmology, University of Melbourne, Melbourne, VIC 3010, Australia; ecosse{at}unimelb.edu.au

Abstract

Background/Aims To determine if selective laser trabeculoplasty (SLT) is superior to topical medication as a first-line treatment for glaucoma on quality of life (QoL) and clinical outcomes.

Methods In this international, longitudinal, multisite randomised controlled trial, treatment naïve mild-to-moderate primary open angle or exfoliation glaucoma patients were randomised 1:1 to SLT or topical medication. Glaucoma-specific QoL (primary outcome) was measured using the Glaucoma Outcomes Assessment Tool (GOAT; 342 items, 12 domains). Secondary outcomes included rate of successful intraocular pressure (IOP) reduction (>25% reduction from baseline) and presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema. Our intention-to-treat analysis was performed at months 12 and 24.

Results Of 167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 (n=75 SLT, n=70 medication) completed 24-month follow-up. While both treatment arms achieved significant within-group gains in GOAT outcomes at both endpoints, SLT patients reported a greater between-group improvement in ‘social well-being’ compared with medication patients (mean±SE=0.28±0.13; p=0.034) at 24 months. At month 24, the rate of successful IOP reduction was 18.6% (95% CI 3.0% to 34.3%, p=0.022) higher (absolute difference) in the medication compared with SLT group. More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.

Conclusion Overall, we did not find evidence that SLT was superior to medication in improving glaucoma-specific QoL. While we found superior IOP reduction in the medication arm, eyelid erythema and conjunctival hyperaemia were more prevalent in these patients compared with the SLT group.

Trial registration ACTRN12611000720910.

  • glaucoma
  • clinical trial

https://doi.org/10.1136/bjophthalmol-2018-313396

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    Footnotes

    • JGC and ELL are joint senior authors.

    • GSA and EKF contributed equally.

    • Contributors GSA and EKF contributed equally as first authors and wrote the manuscript and interpreted the data; MC ran the trial and drafted sections of the paper; ATLG and JX conducted the data analysis, assisted with interpretation of results and drafted sections of the paper; REKM assisted with interpretation of results and drafted sections of the manuscript; RJC, IG, PRH, KP, JJ, APW, AW, KM and MJW contributed to the study protocol; ELL and JGC contributed to the conception of the work and interpretation of the data; all authors revised the manuscript critically for important intellectual content.

    • Funding This Randomised Controlled Trial was funded by a Project Grant from the Australian National Health and Medical Research Council (NHMRC #1009844-EL as PI). CERA receives operational infrastructure support from the Victorian Government. Last and corresponding author ELL was funded by a NHMRC Research Fellowship (#1045280) and co-last author JGC was funded by an NHMRC Practitioner Fellowship (#529915) and by the Dorothy Adele Edols Charitable Trust. Co-main author EKF was funded by an NHMRC Early Career Fellowship (#1072987).

    • Competing interests IG has the following conflicts of interest to declare: Advisory Board member for Allergan, Novartis, Mundipharma; Speaker Bureau for Allergan, Novartis; Travel support from Pfizer. KM has the following conflicts of interest to declare: Consultant to Allergan, Novartis, Quethera, Sensimed.

    • Patient consent for publication Written informed consent was collected from each participant prior to commencement in the study. Recruitment started in 2012 and ceased in 2017.

    • Ethics approval The study was conducted according to the tenets of the Declaration of Helsinki and ethical approval was obtained the Human Research Ethics Committee (HREC) of the Royal Victorian Eye and Ear Hospital (Reference number 11/1024 hour), Westmead Hospital (Reference number 2011/10/4.1 (3391) AU RED HREC/11/WMEAD/229), the Royal Australian and New Zealand College of Ophthalmologists (Reference number 34.11), the Health and Disability Ethics Committees of New Zealand (Reference number 12/STH/13), the Southern Adelaide Clinical Human Research Ethics Committee (Reference number 81.13) and National Research Ethics Services Cambridge East (Reference number 13/EE/0204) the Australian College of Optometry Human Research Ethics Committee (Ref H13 002).

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

    • Data availability statement Data are available upon request.

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