A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy

Ophthalmology. 2004 Dec;111(12):2240-5. doi: 10.1016/j.ophtha.2004.05.036.


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).

Design: Double-masked, prospective, randomized, placebo-controlled clinical trial.

Setting: Three tertiary-referral teaching hospital vitreoretinal surgical units.

Patients: One hundred fifty-seven patients with established PVR (grade C, anterior or posterior) undergoing vitrectomy surgery.

Intervention: 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.

Outcome measures: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antimetabolites / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fibrinolytic Agents / therapeutic use*
  • Fluorouracil / therapeutic use*
  • Heparin, Low-Molecular-Weight / therapeutic use*
  • Humans
  • Male
  • Prospective Studies
  • Retinal Detachment / complications
  • Retinal Detachment / drug therapy
  • Retinal Detachment / surgery
  • Silicone Oils / administration & dosage
  • Treatment Outcome
  • Vitrectomy
  • Vitreoretinopathy, Proliferative / drug therapy*
  • Vitreoretinopathy, Proliferative / etiology
  • Vitreoretinopathy, Proliferative / surgery


  • Antimetabolites
  • Fibrinolytic Agents
  • Heparin, Low-Molecular-Weight
  • Silicone Oils
  • Fluorouracil