Randomized controlled trial of combined 5-Fluorouracil and low-molecular-weight heparin in the management of unselected rhegmatogenous retinal detachments undergoing primary vitrectomy.
OBJECTIVE
To determine the efficacy of a combination of 5-fluorouracil (5FU) and low-molecular-weight heparin (LMWH) in the treatment of unselected rhegmatogenous retinal detachment (RRD) undergoing primary vitrectomy.


METHODS
Double-masked, prospective, randomized, placebo-controlled clinical trial.


METHODS
Six hundred forty-one patients presenting with primary RRD were recruited from 2 specialized vitreoretinal units-Moorfields Eye Hospital, London (n = 553) and St. Pauls Eye Unit, Liverpool (n = 88).


METHODS
All patients underwent primary vitrectomy and gas endotamponade. Adjuvant therapy in the treatment group consisted of 5 IU/ml LMWH and 200 mug/ml 5FU added to the perioperative infusion fluid.


METHODS
The primary outcome measure was retinal reattachment after primary vitrectomy without any reoperations at 6 months. Secondary outcome measures recorded at 6 months were the occurrence and grade of proliferative vitreoretinopathy (PVR), best-corrected visual acuity in logarithm of the minimum angle of resolution, intraocular pressure (mmHg), corneal clarity, and complications.


RESULTS
The overall primary success rate was 84.4%; in the treatment group, the primary success rate was 82.3% compared with 86.8% in the placebo group (P = 0.12). At 6 months, the final complete anatomical reattachment rate was 97.9% in both treatment and placebo groups. The number of patients who failed due to the development of PVR was not statistically significant, 23 in the treatment group (7.0%) and 14 in the placebo group (4.9%) (P = 0.309). There was no significant difference in the mean visual acuity at 6 months in the placebo group (0.48) versus the treatment group (0.53; P = 0.072). The visual acuity at 6 months of patients presenting with a macula-sparing retinal detachment was significantly worse in the treatment group (P = 0.0091). There was no significant difference between the 2 groups in patients who presented with a macula involving retinal detachment (P = 0.896).


CONCLUSIONS
Primary vitrectomy has a high anatomic and visual success rate for RRD. Adjuvant therapy with 5FU and LMWH does not improve the anatomic or visual success rate of unselected primary retinal detachments undergoing vitrectomy. After adjuvant therapy, a worse visual outcome was observed in patients presenting with macula-sparing retinal detachments. A combination of 5FU and LMWH should not be used routinely for primary RRD surgery.
Wickham
L
L
Vitreoretinal Department, Moorfields Eye Hospital, London, United Kingdom. Louisa.Wickham@moorfields.nhs.uk
Bunce
C
C
Wong
D
D
McGurn
D
D
Charteris
D G
DG
D003131:Combined Modality Therapy; D017679:Cryotherapy; D017985:Dalteparin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005466:Fluorocarbons / Q000008:administration & dosage; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D017075:Laser Coagulation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012163:Retinal Detachment / Q000188:drug therapy* / Q000601:surgery*; D013459:Sulfur Hexafluoride / Q000008:administration & dosage; D016896:Treatment Outcome; D014792:Visual Acuity; D014821:Vitrectomy
D005466:Fluorocarbons; C042852:perflutren; D017985:Dalteparin; D005472:Fluorouracil; D013459:Sulfur Hexafluoride