Comparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment the Glaucoma Initial Treatment Study: study protocol for a randomised controlled trialReportar como inadecuado




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Trials

, 16:406

First Online: 11 September 2015Received: 23 December 2014Accepted: 24 August 2015DOI: 10.1186-s13063-015-0924-6

Cite this article as: Lamoureux, E.L., Mcintosh, R., Constantinou, M. et al. Trials 2015 16: 406. doi:10.1186-s13063-015-0924-6

Abstract

BackgroundGlaucoma is the leading cause of irreversible blindness in the world. Estimated to affect 60 million people worldwide, this figure is expected to rise to 80 million by 2020. Untreated, glaucoma leads to visual decay and eventually to blindness, and can significantly reduce quality of life. First-line treatment in patients with primary open-angle glaucoma and exfoliative glaucoma is topical medical therapy with ocular hypotensives as eye drops. However, eye drops have several disadvantages including cost, possible local and systemic side effects, and adherence and perseverance issues. Randomised controlled trials have demonstrated that selective laser trabeculoplasty is equally as effective in lowering intraocular pressure as eye drops. However, the impact of these two treatment modalities from the patient and economic perspectives has not been adequately determined. Thus, it remains unclear whether topical medical therapy or selective laser trabeculoplasty should be recommended as first-line treatment for glaucoma.

Methods-DesignThis protocol describes an international, multi-centre, randomised controlled trial to determine the optimum first-line therapy for people with primary open-angle glaucoma and exfoliative glaucoma. This study will compare the effect of selective laser trabeculoplasty and topical medication with respect to patients’ generic and glaucoma-specific quality of life. The trial will also provide a detailed cost-effectiveness analysis and compare the clinical effectiveness with respect to the degree of intraocular pressure lowering and rates of treatment failure. Research coordinators in each centre will identify and recruit previously untreated patients with primary open-angle glaucoma and exfoliative glaucoma. Those who meet the eligibility criteria will be invited to enter a randomised controlled trial with either selective laser trabeculoplasty or topical ocular hypotensive therapy, according to a stepped regimen. Outcome assessment will be measured at 6 weeks and at 6, 12, and 24 months post-treatment. Regular clinic follow-ups will continue as clinically indicated between study outcome visits.

DiscussionThe Glaucoma Initial Treatment Study is the first multi-centred RCT to determine the optimum first-line therapy for people with glaucoma. Our trial will have an unprecedented capacity to meaningfully transform the treatment and management of glaucoma in Australia and overseas.

Trial registrationACTRN12611000720910; Date registered: 11 July 2011

KeywordsGlaucoma eye drops selective laser trabeculoplasty quality of life cost-effectiveness randomised clinical trial AbbreviationsAEadverse event

AQOL-7DAssessment of Quality of Life - 7 Dimensions

CERACentre for Eye Research Australia

CIconfidence interval

CEACcost effectiveness acceptability curves

CIGTSCollaborative Initial Glaucoma Treatment Study

DSMCData Safety Monitoring Committee

GEEgeneralised estimating equation

Glau-QoLGlaucoma Quality of Life Questionnaire

GLMMgeneralised linear mixed models

GOATGlaucoma Outcome Assessment Tool

GITSGlaucoma Initial Treatment Study

GPAGuided Progression Analysis

HeNehelium-neon laser

HRECHuman Research Ethics Committee

HRQoLHealth-Related Quality of Life

IQRinterquartile range

IRTitem response theory

ITTintention to treat

IOPintraocular pressure

MDmean deviation

NHMRCNational Health and Medical Research Council

NICENational Institute for Health and Care Excellence

NFLDnerve fibre layer defects

OSDocular surface disease

ODOCOptic Disc Outcomes Committee

ORodds ratio

POAGprimary open angle glaucoma

QALYquality-adjusted life year

QoLquality of life

RCTrandomised controlled trial

SAEserious adverse event

SDstandard deviation

SLTselective laser trabeculoplasty

VFOCVisual Field Outcomes Committee

WHOWorld Health Organisation

XFGexfoliative glaucoma

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Autor: Ecosse L. Lamoureux - Rachel Mcintosh - Marios Constantinou - Eva K. Fenwick - Jing Xie - Robert Casson - Eric Finkelstei

Fuente: https://link.springer.com/







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