Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial

Gus Gazzard, Evgenia Konstantakopoulou, David Garway-Heath, Anurag Garg, Victoria Vickerstaff, Rachael Hunter, Gareth Ambler, Catey Bunce, Richard Wormald, Neil Nathwani, Keith Barton, Gary Rubin, Marta Buszewicz, LiGHT Trial Study Group, Gareth Ambler, Keith Barton, Rupert Bourne, David Broadway, Catey Bunce, Marta Buszewicz, Amanda Davis, Anurag Garg, David Garway-Heath, Gus Gazzard, Rachael Hunter, Hari Jayaram, 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, Gus Gazzard, Evgenia Konstantakopoulou, David Garway-Heath, Anurag Garg, Victoria Vickerstaff, Rachael Hunter, Gareth Ambler, Catey Bunce, Richard Wormald, Neil Nathwani, Keith Barton, Gary Rubin, Marta Buszewicz, LiGHT Trial Study Group, Gareth Ambler, Keith Barton, Rupert Bourne, David Broadway, Catey Bunce, Marta Buszewicz, Amanda Davis, Anurag Garg, David Garway-Heath, Gus Gazzard, Rachael Hunter, Hari Jayaram, 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

Abstract

Background: Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two.

Methods: In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223).

Findings: Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained.

Interpretation: Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.

Funding: National Institute for Health Research, Health and Technology Assessment Programme.

Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1
Figure 1
Trial profile SLT=selective laser trabeculoplasty. *Two patients were randomised twice due to computer failure: one was initially randomised to medication but was subsequently randomised to, and received, SLT. The other was initially randomised to SLT but was subsequently randomised to, and received, medication. These patients are included in the figure according to their second randomisations. In addition, four other patients who did not meet the eligibility criteria (and could not receive treatment) were randomised in error. These patients were subsequently removed from the study and are not included in the total randomised.
Figure 2
Figure 2
Mean EQ-5D, GUI, GSS, and GQL-15 scores at each time point, across 36 months Time-point ‘0’ refers to pre-treatment. EQ-5D=EuroQol 5 Dimensions 5 Levels. GUI=Glaucoma Utility Index. GSS=Glaucoma Symptom Scale. GQL-15=Glaucoma Quality of Life-15. *Higher scores indicate better health-related quality of life. †Higher scores indicate worse health-related quality of life.

References

    1. Haymes SA, Leblanc RP, Nicolela MT, Chiasson LA, Chauhan BC. Risk of falls and motor vehicle collisions in glaucoma. Invest Ophthalmol Vis Sci. 2007;48:1149–1155.
    1. Haymes SA, LeBlanc RP, Nicolela MT, Chiasson LA, Chauhan BC. Glaucoma and on-road driving performance. Invest Ophthalmol Vis Sci. 2008;49:3035–3041.
    1. Bunce C, Wormald R. Leading causes of certification for blindness and partial sight in England & Wales. BMC Public Health. 2006;6:58.
    1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262–267.
    1. Garway-Heath DF, Crabb DP, Bunce C. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015;385:1295–1304.
    1. Kass MA, Heuer DK, Higginbotham EJ. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120:701–713.
    1. Kirwan JF, Nightingale JA, Bunce C, Wormald R. Beta blockers for glaucoma and excess risk of airways obstruction: population based cohort study. BMJ. 2002;325:1396–1397.
    1. Broadway DC, Grierson I, O'Brien C, Hitchings RA. Adverse effects of topical antiglaucoma medication. II. The outcome of filtration surgery. Arch Ophthalmol. 1994;112:1446–1454.
    1. Garg A, Gazzard G. Selective laser trabeculoplasty: past, present, and future. Eye. 2018;32:863–876.
    1. Medeiros FA, Gracitelli CP, Boer ER, Weinreb RN, Zangwill LM, Rosen PN. Longitudinal changes in quality of life and rates of progressive visual field loss in glaucoma patients. Ophthalmology. 2015;122:293–301.
    1. Nordmann JP, Auzanneau N, Ricard S, Berdeaux G. Vision related quality of life and topical glaucoma treatment side effects. Health Qual Life Outcomes. 2003;1:75.
    1. Lee R, Hutnik CM. Projected cost comparison of selective laser trabeculoplasty versus glaucoma medication in the Ontario Health Insurance Plan. Can J Ophthalmol. 2006;41:449–456.
    1. Konstantakopoulou E, Gazzard G, Vickerstaff V. The laser in glaucoma and ocular hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics. Br J Ophthalmol. 2018;102:599–603.
    1. Gazzard G, Konstantakopoulou E, Garway-Heath D. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial. A multicentre, randomised controlled trial: design and methodology. Br J Ophthalmol. 2018;102:593–598.
    1. National Institute for Health and Clinical Excellence . DoH; 2010. NICE: Guidance on Glaucoma: Diagnosis and management of chronic open angle glaucoma and ocular hypertension.
    1. Damji KF, Behki R, Wang L, Target IOP Workshop participants Canadian perspectives in glaucoma management: setting target intraocular pressure range. Can J Ophthalmol. 2003;38:189–197.
    1. Mills RP, Budenz DL, Lee PP. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006;141:24–30.
    1. Heijl A, Leske MC, Bengtsson B. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120:1268–1279.
    1. European Glaucoma Society Terminology and Guidelines for Glaucoma 2008. 3rd edn.
    1. American Academy of Ophthalmology Primary Open-Angle Glaucoma: Preferred Practice Pattern. 2005.
    1. SEAGIG. South East Asia Gluacoma Interest Group: Asia Pacific Glaucoma Guidelines. Bangkok, 2003.
    1. Medicines and Healthcare products Regulatory Agency. Good Clinical Practice. London, 2010.
    1. Office of Health Economics OHE Seminar Launches ‘An EQ-5D-5L Value Set for England’.
    1. Burr JM, Kilonzo M, Vale L, Ryan M. Developing a preference-based Glaucoma Utility Index using a discrete choice experiment. Optom Vis Sci. 2007;84:797–808.
    1. Lee BL, Gutierrez P, Gordon M. The Glaucoma Symptom Scale. A brief index of glaucoma-specific symptoms. Arch Ophthalmol. 1998;116:861–866.
    1. Vickerstaff V, Ambler G, Bunce C, Xing W, Gazzard G, LiGHT Trial Study Group Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial. Trials. 2015;16:517.
    1. British National Formulary BMJ Group and Pharmaceutical Press. 2018.
    1. Schwartz GF, Quigley HA. Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008;53(suppl 1):S57–S68.
    1. Greenidge KC, Spaeth GL, Fiol-Silva Z. Effect of argon laser trabeculoplasty on the glaucomatous diurnal curve. Ophthalmology. 1983;90:800–804.
    1. Nagar M, Luhishi E, Shah N. Intraocular pressure control and fluctuation: the effect of treatment with selective laser trabeculoplasty. Br J Ophthalmol. 2009;93:497–501.
    1. Wong MO, Lee JW, Choy BN, Chan JC, Lai JS. Systematic review and meta-analysis on the efficacy of selective laser trabeculoplasty in open-angle glaucoma. Surv Ophthalmol. 2015;60:36–50.
    1. McIlraith I, Strasfeld M, Colev G, Hutnik CM. Selective laser trabeculoplasty as initial and adjunctive treatment for open-angle glaucoma. J Glaucoma. 2006;15:124–130.
    1. Li X, Wang W, Zhang X. Meta-analysis of selective laser trabeculoplasty versus topical medication in the treatment of open-angle glaucoma. BMC Ophthalmol. 2015;15:107.
    1. Nagar M, Ogunyomade A, O'Brart DP, Howes F, Marshall J. A randomised, prospective study comparing selective laser trabeculoplasty with latanoprost for the control of intraocular pressure in ocular hypertension and open angle glaucoma. Br J Ophthalmol. 2005;89:1413–1417.
    1. James Lind Alliance Glaucoma Top 10.
    1. Cantor LB, Katz LJ, Cheng JW, Chen E, Tong KB, Peabody JW. Economic evaluation of medication, laser trabeculoplasty and filtering surgeries in treating patients with glaucoma in the US. Curr Med Res Opin. 2008;24:2905–2918.
    1. Saunders LJ, Russell RA, Kirwan JF, McNaught AI, Crabb DP. Examining visual field loss in patients in glaucoma clinics during their predicted remaining lifetime. Invest Ophthalmol Vis Sci. 2014;55:102–109.
    1. Saunders LJ, Russell RA, Crabb DP. Practical landmarks for visual field disability in glaucoma. Br J Ophthalmol. 2012;96:1185–1189.
    1. Aspinall PA, Johnson ZK, Azuara-Blanco A, Montarzino A, Brice R, Vickers A. Evaluation of quality of life and priorities of patients with glaucoma. Invest Ophthalmol Vis Sci. 2008;49:1907–1915.

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