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Ophthalmology. 2004 Dec;111(12):2240-5.

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

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1
Department of Vitreoretinal Surgery, Moorfields Eye Hospital, London, United Kingdom.

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.

PMID:
15582080
DOI:
10.1016/j.ophtha.2004.05.036
[Indexed for MEDLINE]
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