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H. Heimann, K.–U. Bartz–Schmidt, N. Bornfeld, R.–D. Hilgers, M. Nodov, C. Weiss, M.H. Foerster, SPR Study Group; Results of the Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study (SPR Study) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2690.
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To compare scleral buckling surgery (SBS) and primary vitrectomy (PPPV) in the treatment of rhegmatogenous retinal detachment (RRD) of medium complexity.
Prospective randomized multicentre clinical trial of two subtrials: Pseudophakic/aphakic (p/a. group) and phakic patients (ph. group), each subtrial comparing treatment arms with SBS and PPPV. 46 surgeons in 25 centres in 5 European countries participated in the trial. The main endpoint was defined as change in visual acuity (VA) at 12 months follow–up. Secondary endpoints were primary success without retina affecting reoperations, number of reoperations and catarct–surgeries (ph. Group), PVR rate and final anatomical success rate.
681 patients (265 p/a. subtrial, 416 ph. subtrial) were recruited. The mean changes in VA were in the p/a. subtrial –0.557 (SD 0.783) LogMar (SBS) and –0.646 (SD 0.686) (PPPV), and in the ph. subtrial –0.705 (SD 0.670) (SBS) and –0.571 (SD 0.759) (PPV) with no statistically significant difference (p/a.: p = 0.2814; ph.: p = 0.1147). Redetachment rates were in the p/a. subtrial 38.4% (48/125 SBS) and 21.6% (24/111 PPPV) and in the ph. subtrial 26.3% (51/194 SBS) and 27.6% (53/192 PPPV). In the p/a. subtrial, primary success rates (p=0.0167) and the number of retina–affecting reoperations (p=0.0161) demonstrated an advantage for PPPV, especially when combined with buckling elements. In the ph. subtrial, patients treated with SBS had significantly less cataract operations during follow–up (p<0.00005). No significant differences were found within the p/a. subtrial for final anatomical success (p = 0.9078) and PVR Grade B or C (p = 0.1879). In the phakic subtrial, comparison of primary (p = 0.9137) as well as final anatomical success (p = 0.8634) did not show significat difference, neither did comparison of PVR rates (p = 0.1938) or number of retina–affecting reoperations (p = 0.1269).
No differences between SBS and PPPV could be seen regarding the main endpoint in pseudophakic as well as phakic patients. Based on the analysis of secondary endpoints, PPPV combined with scleral buckling is recommended in the p/a. group. In the ph. group, SBS is recommended due to the fewer number of secondary cataract surgeries.
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