title: A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy.
abstract: OBJECTIVE
  To determine the efficacy of a combination of 5-fluorouracil and low-molecular-weight heparin (LMWH) to improve the outcome of surgery for established proliferative vitreoretinopathy (PVR).
  
  
  METHODS
  Double-masked, prospective, randomized, placebo-controlled clinical trial.
  
  
  METHODS
  Three tertiary-referral teaching hospital vitreoretinal surgical units.
  
  
  METHODS
  One hundred fifty-seven patients with established PVR (grade C, anterior or posterior) undergoing vitrectomy surgery.
  
  
  METHODS
  All patients underwent vitreoretinal surgery and silicone oil exchange with or without membrane peeling and/or retinectomy. Patients were randomly allocated to perioperative infusion with or without 5-fluorouracil (200 microg/ml) and LMWH (5 IU/ml) in Hartmann's solution for 1 hour.
  
  
  METHODS
  The primary outcome measure was defined as posterior retinal reattachment after removal of silicone oil without any reoperations at 6 months. Secondary outcome measures recorded were posterior retinal reattachment, localized/tractional retinal detachment, visual acuity, macular pucker, hypotony, glaucoma, keratopathy, and cataract. Removal of silicone oil and reoperations were also recorded.
  
  
  RESULTS
  Overall, at 6 months 84% of patients had full retinal reattachment and 94% had stable posterior retinal reattachment. There was no significant difference in success in the primary outcome measure (56%, treatment group; 51%, placebo group; P = 0.59) or in secondary outcome measures or rates of complications. Secondary macular pucker occurred less often in the treatment group (6% vs. 17% at 6 months, P = 0.068).
  
  
  CONCLUSIONS
  A perioperative infusion of combined 5-fluorouracil and LMWH does not significantly increase the success rate of vitreoretinal surgery for established PVR.
authors.affiliation: Department of Vitreoretinal Surgery, Moorfields Eye Hospital, London, United Kingdom.
authors.forename: David G
authors.initials: DG
authors.lastname: Charteris
authors.forename: G William
authors.initials: GW
authors.lastname: Aylward
authors.forename: David
authors.initials: D
authors.lastname: Wong
authors.forename: Carl
authors.initials: C
authors.lastname: Groenewald
authors.forename: Riaz H Y
authors.initials: RH
authors.lastname: Asaria
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
mesh_terms: D000368:Aged; D000963:Antimetabolites / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005472:Fluorouracil / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012163:Retinal Detachment / Q000150:complications / Q000188:drug therapy / Q000601:surgery; D012827:Silicone Oils / Q000008:administration & dosage; D016896:Treatment Outcome; D014821:Vitrectomy; D018630:Vitreoretinopathy, Proliferative / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery
chemical_list: D000963:Antimetabolites; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D012827:Silicone Oils; D005472:Fluorouracil