title: Ozurdex (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Proliferative vitreoretinopathy (PVR) is the commonest cause of late anatomical failure in rhegmatogenous retinal detachment. Visual and anatomical outcomes remain poor despite advances in vitreoretinal surgical techniques with reported primary failure rates of up to nearly 50%. Numerous adjunctive medications have been evaluated in clinical trials with no agent gaining widespread acceptance and use.This study was designed to investigate the benefits of using a slow-release dexamethasone implant delivered intra-operatively in patients undergoing vitrectomy surgery for retinal detachment with established PVR.
  
  
  METHODS
  For the study, 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR will be randomised to receive either standard treatment or study treatment in a 1:1 treatment allocation ratio. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine peri-operative treatment and care, differing only in the addition of the supplementary adjunctive agent in the treatment group. The investigated primary outcome measure is stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months.
  
  
  CONCLUSIONS
  This is the first randomised controlled clinical trial to investigate the use of an adjunctive slow-release dexamethasone implant in patients undergoing vitrectomy surgery for retinal detachments with proliferative vitreoretinopathy.
  
  
  BACKGROUND
  EudraCT No: 2011-004498-96.
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, City Road, EC1V 2PD London, UK. philip.banerjee@moorfields.nhs.uk.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Banerjee
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.forename: David G
authors.initials: DG
authors.lastname: Charteris
mesh_terms: D002985:Clinical Protocols; D003907:Dexamethasone / Q000008:administration & dosage*; D004343:Drug Implants; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007430:Intraoperative Care; D012107:Research Design; D012163:Retinal Detachment / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D012827:Silicone Oils / Q000627:therapeutic use; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014821:Vitrectomy; D018630:Vitreoretinopathy, Proliferative / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D012827:Silicone Oils; D003907:Dexamethasone