title: Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial.
abstract: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical techniques, outcomes in these patients remain unsatisfactory, and development of the intraocular scarring response proliferative vitreoretinopathy is the leading cause. Proliferative vitreoretinopathy is the most common cause of recurrent retinal detachment in these eyes; it is reported to occur in up to 45 % of cases.
  
  
  
  The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a multi-centre, double-masked, parallel-arm randomised controlled trial with an internal pilot designed to investigate the effectiveness and cost-effectiveness of using intravitreal and sub-Tenon's triamcinolone acetonide peri-operatively in patients undergoing vitrectomy following open globe trauma. In total, 300 eyes of 300 patients will be recruited and randomly allocated to one of two treatment groups. Both groups will receive standard surgical treatment and routine pre-operative and post-operative treatment and care. The treatment group will receive an adjunctive peri-operative steroid combination (triamcinolone acetonide) consisting of 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml into the sub-Tenon's space. The trial incorporates a two-stage internal pilot to examine projected recruitment and retention rates. Progression criteria from the internal pilot study will enable us to determine whether to undertake the main trial. Patients and primary outcome assessors will be masked to treatment allocation. The primary outcome will be an improvement from baseline to 6 months of at least 10 on the corrected visual acuity as measured by ETDRS letter score. Secondary outcomes will be development of scarring, retinal detachment, intraocular pressure abnormalities, quality of life and public sector service use.
  
  
  
  This is the first powered, controlled clinical trial to investigate the use of adjunctive triamcinolone in patients undergoing vitrectomy following open globe trauma.
  
  
  
  EudraCT2014-002193-37 . Registered on 5 September 2014. ISRCTN30012492 . Registered on 5 September 2014.
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.|National Institute for Health Research (NIHR) Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Banerjee
authors.affiliation: Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
authors.forename: Victoria R
authors.initials: VR
authors.lastname: Cornelius
authors.affiliation: Department of Primary Care and Public Health Sciences, King's College London, London, UK. rachel.phillips@kcl.ac.uk.|National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St. Thomas' NHS Foundation Trust and King's College London, London, UK. rachel.phillips@kcl.ac.uk.
authors.forename: Rachel
authors.identifier: 0000-0002-3634-7845
authors.initials: R
authors.lastname: Phillips
authors.affiliation: Department of Primary Care and Public Health Sciences, King's College London, London, UK.|National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St. Thomas' NHS Foundation Trust and King's College London, London, UK.
authors.forename: Jessica W
authors.initials: JW
authors.lastname: Lo
authors.affiliation: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, UK.|University College London Institute of Ophthalmology, London, UK.
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.affiliation: King's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Kelly
authors.affiliation: King's Clinical Trials Unit, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.affiliation: Bangor University, Bangor, UK.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.|National Institute for Health Research (NIHR) Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Elizabeth L
authors.initials: EL
authors.lastname: Robertson
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, City Road, London, EC1V 2PD, UK.|National Institute for Health Research (NIHR) Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: David G
authors.initials: DG
authors.lastname: Charteris
mesh_terms: D060433:Administration, Ophthalmic; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D016527:Drug Costs; D005131:Eye Injuries / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D017721:Hospital Costs; D006801:Humans; D010865:Pilot Projects; D012107:Research Design; D012163:Retinal Detachment / Q000191:economics / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D006113:United Kingdom; D014785:Vision, Ocular; D057586:Vitreoretinal Surgery / Q000009:adverse effects* / Q000191:economics; D018630:Vitreoretinopathy, Proliferative / Q000191:economics / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*
chemical_list: D005938:Glucocorticoids; D014222:Triamcinolone Acetonide
keywords: ETDRS; Open globe trauma; Ophthalmology; Proliferative vitreoretinopathy; Randomised controlled trial; Visual acuity