title: Triamcinolone during pars plana vitrectomy for open globe trauma: a pilot randomised controlled clinical trial.
abstract: OBJECTIVE
  To investigate the feasibility of conducting a randomised controlled trial in patients undergoing pars plana vitrectomy surgery following open globe trauma (OGT). Additionally, to investigate the treatment effect and toxicity of intensive anti-inflammatory agents.
  
  
  METHODS
  A 2-year, pilot, single-centre prospective, participant and surgeon-masked randomised controlled trial (RCT). Forty patients requiring vitrectomy surgery following OGT were randomised to either standard (control) or study treatment (adjuncts) in a 1:1 allocation ratio. Perioperatively, the adjunct group received intravitreal and subtenons triamcinolone acetonide, oral flurbiprofen and guttae prednisolone acetate 1%. The control group received standard care. Primary outcome was anatomical success at 6 months. Secondary outcomes included final visual acuity, occurrence of proliferative vitreoretinopathy, intraocular pressure rise, number of operations and recruitment rate.
  
  
  RESULTS
  40 patients were recruited within 21 months. Primary outcome assessment showed similar results in anatomical success with 50% (10/20) in the adjunct group compared with 47% (9/19) in the standard group (OR 1.11, 95% CI 0.316 to 3.904). Visual outcomes were better in the adjunct group with a final median visual acuity of 31 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with 25 ETDRS letters in the standard group. A higher proportion of patients gained 10, 20 and 30 ETDRS letters in the adjunct group (80%, 65% and 50%, respectively) compared with the standard group (52.6%, 52.6% and 42.1%). Fewer adjunct patients (15%, n=3) had poor visual outcomes (Zero ETDRS letters) compared with 42.1%, (n=8).
  
  
  CONCLUSIONS
  An RCT in this population is deliverable and estimated recruitment rates are realistic. Results and patient discussions determined that the definitive study should have vision as a primary outcome. This pilot study is supportive of there being a positive treatment effect of intensive anti-inflammatory agents in OGT.
  
  
  BACKGROUND
  European Clinical Trials Database 2007-005138-35; Results.
authors.affiliation: Moorfields Eye Hospital, London, UK.|NIHR Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Banerjee
authors.affiliation: Moorfields Eye Hospital, London, UK.|NIHR Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Wen
authors.initials: W
authors.lastname: Xing
authors.affiliation: Moorfields Eye Hospital, London, UK.|NIHR Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.affiliation: Royal Air force and Worcestershire Acute Hospitals NHS Trust, Worcester, UK.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Woodcock
authors.affiliation: Moorfields Eye Hospital, London, UK.|NIHR Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: Aman
authors.initials: A
authors.lastname: Chandra
authors.affiliation: Birmingham and Midland Eye Centre, Birmingham, UK.
authors.forename: Robert A H
authors.initials: RA
authors.lastname: Scott
authors.affiliation: Moorfields Eye Hospital, London, UK.|NIHR Clinical Research Facility at Moorfields Eye Hospital, London, UK.
authors.forename: David G
authors.initials: DG
authors.lastname: Charteris
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D015807:Eye Injuries, Penetrating / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007432:Intraoperative Period; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage*; D014821:Vitrectomy / Q000379:methods*; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D014222:Triamcinolone Acetonide
keywords: Eye (Globe); Inflammation; Trauma; Treatment Surgery