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).

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.

• Authors: David G Charteris, G William Aylward, David Wong, Carl Groenewald, Riaz H Y Asaria, Catey Bunce, PVR Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 111 Issue 12 Pg. 2240-5 (Dec 2004) ISSN: 1549-4713 [Electronic] United States
• PMID: 15582080 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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, drug therapy, surgery)
• Silicone Oils (administration & dosage)
• Treatment Outcome
• Vitrectomy
• Vitreoretinopathy, Proliferative (drug therapy, etiology, surgery)