A randomized controlled trial of combined 5-fluorouracil and low-molecular-weight heparin in management of established proliferative vitreoretinopathy.
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.
Charteris
David G
DG
Department of Vitreoretinal Surgery, Moorfields Eye Hospital, London, United Kingdom.
Aylward
G William
GW
Wong
David
D
Groenewald
Carl
C
Asaria
Riaz H Y
RH
Bunce
Catey
C
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
D000963:Antimetabolites; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D012827:Silicone Oils; D005472:Fluorouracil