title: Comparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment (the Glaucoma Initial Treatment Study): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Glaucoma 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
  This 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ACTRN12611000720910; Date registered: 11 July 2011.
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. ecosse@unimelb.edu.au.|Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore. ecosse@unimelb.edu.au.|Duke, Graduate Medical School, Singapore, Singapore. ecosse@unimelb.edu.au.
authors.forename: Ecosse L
authors.initials: EL
authors.lastname: Lamoureux
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. mcintosh.rachel1@gmail.com.
authors.forename: Rachel
authors.initials: R
authors.lastname: Mcintosh
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. mariosc@unimelb.edu.au.
authors.forename: Marios
authors.initials: M
authors.lastname: Constantinou
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. fenwicke@unimelb.edu.au.
authors.forename: Eva K
authors.initials: EK
authors.lastname: Fenwick
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. sophia.xie@unimelb.edu.au.
authors.forename: Jing
authors.initials: J
authors.lastname: Xie
authors.affiliation: University of Adelaide, North Terrace, Adelaide, South Australia, Australia. casson.robert@gmail.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Casson
authors.affiliation: Duke, Graduate Medical School, Singapore, Singapore. eric.finkelstein@duke-nus.edu.sg.
authors.forename: Eric
authors.initials: E
authors.lastname: Finkelstein
authors.affiliation: Discipline of Ophthalmology, University of Sydney, Sydney, New South Wales, Australia. eyegoldberg@gmail.com.|Glaucoma Unit, Sydney Eye Hospital, Sydney, New South Wales, Australia. eyegoldberg@gmail.com.|Eye Associates, Sydney, New South Wales, Australia. eyegoldberg@gmail.com.
authors.forename: Ivan
authors.initials: I
authors.lastname: Goldberg
authors.affiliation: Centre for Vision Research, Department of Ophthalmology and Westmead Millennium Institute, University of Sydney, Sydney, NSW, Australia. phealey@glaucoma.net.au.
authors.forename: Paul
authors.initials: P
authors.lastname: Healey
authors.affiliation: Queensland Eye Institute, 149 Melbourne Street, South Brisbane, Queensland, Australia. ravi.thomas@qei.org.au.|University of Queensland, Brisbane, Queensland, Australia. ravi.thomas@qei.org.au.
authors.forename: Ravi
authors.initials: R
authors.lastname: Thomas
authors.affiliation: Royal Victorian Eye and Ear Hospital, Victoria, Australia. Brian.Ang@eyeandear.org.au.
authors.forename: Ghee Soon
authors.initials: GS
authors.lastname: Ang
authors.affiliation: NH&MRC Centre for Clinical Eye Research, Discipline of Optometry and Vision Science, Flinders University and Flinders Medical Centre-Australia, Adelaide, Australia. konrad.pesudovs@flinders.edu.au.
authors.forename: Konrad
authors.initials: K
authors.lastname: Pesudovs
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, the Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia. crowston@unimelb.edu.au.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Crowston
mesh_terms: D060433:Administration, Ophthalmic; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005901:Glaucoma / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D053685:Laser Therapy / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D009883:Ophthalmic Solutions; D012107:Research Design; D013997:Time Factors; D014130:Trabeculectomy / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014785:Vision, Ocular / Q000187:drug effects*
chemical_list: D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions