title: Slow-Release Dexamethasone in Proliferative Vitreoretinopathy: A Prospective, Randomized Controlled Clinical Trial.
abstract: To test the hypothesis that adjunctive slow-release dexamethasone implant (Ozurdex; Allergan Inc, Irvine, CA) can improve the outcomes of vitreoretinal surgery for established proliferative vitreoretinopathy (PVR).
  
  
  
  A 2-year, single-center, prospective, participant- and surgeon-masked randomized controlled clinical trial (EudraCT No. 2011-004498-96).
  
  
  
  A total of 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR (Grade C) were randomized to standard (control) or study treatment (adjunct) in a 1:1 allocation ratio.
  
  
  
  Intraoperatively, the adjunct group received an injection of 0.7 mg of slow-release dexamethasone (Ozurdex) at the time of (1) vitrectomy surgery and (2) silicone oil removal. The control group received standard care.
  
  
  
  Primary outcome measure was the proportion of patients with a stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months. Secondary outcomes included (1) final visual acuity (VA) (median and Early Treatment Diabetic Retinopathy Study [ETDRS] of 55 letters or better); (2) cystoid macular edema (CMO), foveal thickness, and macular volume; (3) development of overt PVR recurrence; (4) complete and posterior retinal reattachment; (5) tractional retinal detachment; (6) hypotony/increased intraocular pressure (IOP); (7) macula pucker/epiretinal membrane; (8) cataract; and (9) quality of life.
  
  
  
  All 140 patients were recruited within 25 months of study commencement; 138 patients had primary outcome data. Primary outcome assessment showed similar results in anatomic success between the 2 groups (49.3% vs. 46.3%, adjunct vs. control; odds ratio, 0.89; 95% confidence interval, 0.46-1.74; P = 0.733). Mean VA at 6 months was 38.3 ETDRS letters and 40.2 letters in the adjunct and control groups, respectively. Secondary anatomic outcomes (complete/posterior reattachment rates and PVR recurrence) were comparable between the 2 groups. At 6 months, fewer adjunct patients had CMO (42.7%) or a foveal thickness of >300 μm (47.6%) compared with controls (67.2% and 67.7%, respectively, P = 0.004, P = 0.023).
  
  
  
  A slow-release dexamethasone implant did not improve the primary anatomic success rate in eyes undergoing vitrectomy surgery with silicone oil for PVR. Further clinical trials are indicated to improve anatomic and visual outcomes in these eyes, but this study suggests that there is a greater reduction in CMO observed at 6 months in vitrectomized eyes treated with slow-release dexamethasone.
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom. Electronic address: philipbanerjee@doctors.org.uk.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Banerjee
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Ana
authors.initials: A
authors.lastname: Quartilho
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Wen
authors.initials: W
authors.lastname: Xing
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Tapiwa M
authors.initials: TM
authors.lastname: Zvobgo
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Nicola
authors.initials: N
authors.lastname: Harris
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom; NIHR Clinical Research Facility at Moorfields Eye Hospital, London, United Kingdom.
authors.forename: David G
authors.initials: DG
authors.lastname: Charteris
mesh_terms: D000368:Aged; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004343:Drug Implants; D058450:Endotamponade; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012163:Retinal Detachment / Q000601:surgery*; D012827:Silicone Oils / Q000008:administration & dosage; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy / Q000379:methods; D057586:Vitreoretinal Surgery; D018630:Vitreoretinopathy, Proliferative / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D012827:Silicone Oils; D003907:Dexamethasone