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R-HY Asaria, CH Kon, C Bunce, A Laidlow, DG Charteris, D Wong, PT Khaw, GW Aylward; Adjuvant 5-fluorouracil and Heparin Therapy for Proliferative Vitreoretinopathy: Results From a Randomised Double Blind Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3004.
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Purpose: To access the safety and efficacy of adjuvant combination therapy using 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) in patients with established PVR undergoing vitrectomy for retinal reattachment surgery. Methods: A multicenter, randomised, double blind placebo controlled trial. 157 patients with preoperative PVR (grade CP1 plus) were randomised to receive either 5-FU and LMWH or placebo. Patients were selected from all patients undergoing vitrectomy for rhegmatogenous retinal detachment with PVR. Standard surgery with combination therapy or placebo was compared at the 6-month follow up. Outcome measures were: primary success rate, number of reoperations, complete posterior retinal attachment, development of new postoperative PVR, visual acuity, macular pucker, hyoptony, glaucoma, keratopathy and cataract. Results: There were 73 patients in the 5-FU/heparin therapy group and 84 in the placebo group. There was no statistical difference in the main outcome measure of the primary success rate between either treatment group (p=0.871). There was no statistical difference in the final reattachment rate between the two groups. The visual acuity outcomes were also similar in the two groups. There were no differences in complication rates between the two groups. Conclusion: There was no statistically significant benefit of using adjuvant therapy for the treatment of severe PVR. This is in contrast to the statistically significant effect adjuvant therapy has in the preventative treatment of PVR. Therefore adjuvant 5-FU/heparin therapy probably has a limited role in the treatment of severe established PVR but should be used as preventative treatment in patients at high risk of PVR.
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