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Br J Ophthalmol. 2018 May;102(5):593-598. doi: 10.1136/bjophthalmol-2017-310877. Epub 2017 Sep 13.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

Author information

1
NIHR Biomedical Research Centre at Moorfields, Eye Hospital NHS Foundation Trust, London, UK.
2
Institute of Ophthalmology, University College, London, UK.
3
Centre for Public Health Research, School of Health Sciences, City University, London, UK.
4
Department of Applied Health Research, Institute of Epidemiology and Health Care, University College London, London, UK.
5
Priment Clinical Trials Unit, University College London, Royal Free Medical School, London, UK.
6
Research Department of Primary Care and Population Health, University College Medical School, London, UK.
7
Department of Statistical Science, Faculty of Mathematics and Physical Sciences, University College London, London, UK.
8
International Centre for Eye Health (ICEH), Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.
9
Department of Primary Care and Public Health, King's College London, London, UK.

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:

The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis.

CONCLUSIONS:

The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication.

TRIAL REGISTRATION NUMBER:

ISRCTN32038223, Pre-results.

KEYWORDS:

glaucoma; intraocular pressure; treatment lasers

[Indexed for MEDLINE]

Conflict of interest statement

Competing interests: GG, DG-H, KB, RW, SM, RH, GR, MB, GA and CB have received a grant from the National Institute for Health Research for the submitted work. DG-H and RW have received financial support through the Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology. GG received a research grant from Lumenis prior to the submitted work. GG, DG-H and KB have conflicts of interest outside the submitted work.

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