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L. Wickham, C. Bunce, D. Wong, D.G. Charteris; A Randomised Control Trial Investigating the Use of 5 Fluorouracil and Low Molecular Weight Heparin in the Treatment of Unselected Primary Rhegmatogenous Retinal Detachments . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4209.
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© ARVO (1962-2015); The Authors (2016-present)
Prospective double masked randomised controlled trial to determine the effect of adjuvant therapy with 5–Fluorourocil (5FU) and Low Molecular Weight Heparin (LMWH) in the treatment of unselected rhegmatogenous retinal detachment (RRD) undergoing primary vitrectomy.
641 patients presenting with a primary RRD were recruited. 342 patients were randomly allocated to the treatment group and 299 to the placebo group. All patients underwent a primary vitrectomy and intraocular gas tamponade. Adjuvant therapy in the treatment group consisted of 5IU/ml LMWH and 200ug/ml 5–FU at the time of vitrectomy. Patients were then followed for six months. Data on presenting visual acuity (VA), characteristics of the detachment, operative techniques, anatomical outcome and final VA were collected.
There were no significant differences in the presenting VA, detachment characteristics and operative techniques in the treatment group and placebo group. The primary anatomical success rate of the treatment group was 81.0% compared with 86.5% in the placebo group (p=0.081). At six months the final anatomical success rate was 97.6% in the placebo group and 98.0% in the treatment group (p=0.87). The number of patients who failed due to the development of proliferative vitreoretinopathy (PVR) did not differ significantly between the two groups (p=1.00). There was no significant difference in the mean final VA in the placebo group (0.48) versus the treatment group (0.53)(p=0.072). The final VA of patients presenting with a macula sparing RRD was significantly worse in the treatment group (p=0.0091). There was no significant difference between the two groups in patients who presented with a macula involving RRD (p=0.0896). A PVR risk assessment at the time of presentation demonstrated a significantly lower success rate in the low risk treatment group vs the placebo group (p=0.014). The number of high risk patients was small (n=54), however there was a trend for an improved success rate in the treatment group.
Adjuvant therapy with 5FU and LMWH does not improve the anatomical or visual success rate of unselected primary RRD undergoing vitrectomy. Following adjuvant therapy a worse visual outcome was observed in patients presenting with a macula on RRD and those deemed to have a "low risk" of PVR. We would advise retinal surgeons that 5FU and LMWH should not be used routinely for primary RRD surgery but should be reserved for high risk cases.
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