Abstract
Abstract: :
Purpose: To evaluate the efficacy and safety of adjunctive 5–fluorouracil (5–FU) and low molecular weight heparin (LMWH) on recurrence of retinal detachment rates in patients with complicated rhegmatogenous retinal detachment (RRD) managed with pars plana vitrectomy (PPV). Methods: Prospective, randomized, double blind, placebo controlled study. The cases planned for PPV for RRD between April 2003 and May 2004 were randomly seperated into 2 groups. During PPV, 5–FU (200 µg/ml) and LMWH (clexan, 5 IU/ml) were added into the infusate in the first group whereas BSS was added in the second group as placebo. Opthalmological examination (best corrected visual acuity/BCVA, biomicroscopy, intraocular pressure/ IOP, dilated fundoscopy) were performed preoperatively and on the 1st day, 1st week, 1st, 3rd and 6th month postoperatively. The patients followed–up for at least 6 months were included in the study. The anatomical and functional outcomes of the surgeries, reoperation and complication rates were evaluated and compared between the two groups. Results: The study involved 82 eyes of 82 patients (53 male, 29 female) with a mean age of 47 (7–62) years. The first group (n: 41) included 15 eyes with posttraumatic RD, 21 eyes with severe (≥ C 2) PVR, 5 eyes with giant retinal tears (GRT) with severe PVR. The second group included (n: 41) 14 eyes with posttraumatic RD, 24 eyes with severe (≥ C 2) PVR, 3 eyes with GRT. All of the eyes had total retinal detachment with macular involvement. Preoperative median PVR grade was C3 (A–D3) in both groups. Preoperative median best corrected visual acuity (BCVA) was hand motion in both groups. Throughout mean follow–up time of 8.94 (6–15) months, 10 (% 24) eyes in the first group and 19 eyes (% 46) in the second group underwent reoperation for recurrent retinal detachment due to PVR. Recurrent retinal detachment was significantly higher in the placebo group (p< 0.05). Postoperative median BCVA increased in both groups. There was no significant difference (p>0.05) between first and placebo groups in terms of postoperative complications (fibrin, hemorrhage, IOP elevation, corneal edema). Conclusions: Lower rates of redetachment is detected in cases with complicated RRD managed with PPV in which 5–FU and LMWH were added in the infusate during PPV compared with the placebo. Adjuvant 5–FU and LMWH is also found to be well–tolerated and safe without any additional complications. Its use in complicated RRD should be considered.
Keywords: proliferative vitreoretinopathy • vitreoretinal surgery • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled