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首页> 外文期刊>Ophthalmology >Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study.
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Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study.

机译：巩膜屈曲与原发性玻璃体切除术在流源性视网膜脱离中的关系：一项前瞻性随机多中心临床研究。

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OBJECTIVE: To compare scleral buckling surgery (SB) and primary pars plana vitrectomy (PPV) in rhegmatogenous retinal detachments of medium complexity. DESIGN: Prospective randomized multicenter clinical trial (the Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study), separated into phakic or aphakic/pseudophakic eyes. Patients were enrolled over a 5-year period. There was 1-year follow up in the study, and the primary outcome was assessed at 1 year. PARTICIPANTS: Forty-five surgeons (25 centers, 5 European countries) recruited 416 phakic and 265 pseudophakic patients. Completion of follow-up was achieved in 93% of the phakic and 89% of the pseudophakic patients. INTERVENTION: Scleral buckling surgery with the potential use of multiple sponges, encircling elements, drainage, and intraocular injections. Primary vitrectomy included 3-port vitrectomy with sulfur hexafluoride-air tamponade; additional SB was left to the surgeon's decision. MAIN OUTCOME MEASURES: Primary study end point: change in best-corrected visual acuity (BCVA); secondary end points: primary and final anatomical success, proliferative vitreoretinopathy, cataract progression, and number of reoperations. RESULTS: In the phakic trial, the mean BCVA change was significantly (P = 0.0005) greater in the SB group (SB, -0.71 logarithm of the minimum angle of resolution [logMAR], standard deviation [SD] 0.68; PPV, -0.56 logMAR, SD 0.76). In the pseudophakic trial, changes in BCVA showed a nonsignificant difference of 0.09 logMAR. In phakic patients, cataract progression was greater in the PPV group (P<0.00005). In the pseudophakic group, the primary anatomical success rate (defined as retinal reattachment without any secondary retina-affecting surgery; SB, 71/133 [53.4%]; PPV, 95/132 [72.0%]) was significantly better (P = 0.0020), and the mean number of retina-affecting secondary surgeries (SB, 0.77, SD 1.08; PPV, 0.43, SD 0.85) was lower (P = 0.0032) in the PPV group. Redetachment rates were 26.3% (SB; 55/209) and 25.1% (PPV; 52/207) in the phakic trial and 39.8% (SB; 53/133) and 20.4% (PPV; 27/132) in the pseudophakic trial. CONCLUSIONS: The study shows a benefit of SB in phakic eyes with respect to BCVA improvement. No difference in BCVA was demonstrated in the pseudophakic trial; based on a better anatomical outcome, we recommend PPV in these patients.
机译：目的：比较巩膜屈曲手术（SB）和原发性平面玻璃体切除术（PPV）在中等复杂度的血源性视网膜脱离中的作用。设计：前瞻性随机多中心临床试验（在发源性视网膜脱离研究中进行巩膜屈曲与原发玻璃体切除术），分为有晶状眼或无晶状体/假性眼。患者入组了5年。该研究进行了1年的随访，并在1年时评估了主要结局。参与者：四十五名外科医生（25个中心，5个欧洲国家）招募了416名晶状体晶状体和265名假晶状体患者。 93％的晶状体眼和89％的假晶状体患者完成了随访。干预：巩膜屈曲手术，可能会使用多个海绵，环绕元件，引流和眼内注射。原发性玻璃体切除术包括三孔玻璃体切除术和六氟化硫空气填塞;额外的SB留给外科医生决定。主要观察指标：主要研究终点：最佳矫正视力（BCVA）改变;次要终点：主要和最终的解剖学成功，增生性玻璃体视网膜病变，白内障进展和再次手术的次数。结果：在有晶体眼的试验中，SB组的平均BCVA变化显着（P = 0.0005）（SB，最小分辨角[logMAR]的-0.71对数，标准差[SD] 0.68; PPV，-0.56 logMAR，SD 0.76）。在假晶状体试验中，BCVA的变化显示0.09 logMAR的差异无统计学意义。在有晶状体眼的患者中，PPV组白内障进展更大（P <0.00005）。在假晶状体组中，主要的解剖成功率（定义为不进行任何二次视网膜手术的视网膜复位; SB，71/133 [53.4％]; PPV，95/132 [72.0％]）明显更好（P = 0.0020 ），PPV组的视网膜平均二次手术次数（SB，0.77，SD 1.08; PPV，0.43，SD 0.85）较低（P = 0.0032）。在有晶状体眼试验中，再脱离率分别为26.3％（SB; 55/209）和25.1％（PPV; 52/207），在假晶状体试验中为39.8％（SB; 53/133）和20.4％（PPV; 27/132） 。结论：该研究表明SBK在有晶状体眼中对改善BCVA有好处。在假晶状体试验中未发现BCVA的差异。基于更好的解剖结果，我们建议在这些患者中使用PPV。

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