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The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).
Ophthalmology ( IF 13.1 ) Pub Date : 2018-11-22 , DOI: 10.1016/j.ophtha.2018.11.014
Roxane J Hillier 1 , Tina Felfeli 2 , Alan R Berger 3 , David T Wong 3 , Filiberto Altomare 3 , David Dai 4 , Louis R Giavedoni 3 , Peter J Kertes 5 , Radha P Kohly 5 , Rajeev H Muni 6
Affiliation  

PURPOSE The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for the management of primary RRD. DESIGN Prospective, randomized controlled trial. PARTICIPANTS Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina. METHODS Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively. MAIN OUTCOME MEASURES The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success. RESULTS One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001). CONCLUSIONS Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfilling Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.

中文翻译:

气动性视网膜手术与玻璃体切除术治疗原发性血源性视网膜脱离的结果随机试验(PIVOT)。

目的修复血源性视网膜脱离(RRD)的最佳手术尚不清楚。这项试验的目的是比较气动性视网膜手术(PnR)与平板玻璃体切除术(PPV)在治疗原发性RRD中的疗效。设计前瞻性,随机对照试验。参与者RRD患者在8点和4点子午线上方1个时钟小时内显示单个视网膜断裂或一组脱离的视网膜断裂,视网膜断裂的数量,位置和大小或附着视网膜的晶格变性均不限。方法将患者随机分为PnR或PPV。黄斑病患者和黄斑病患者通过分层随机分为干预组,分别在24小时和72小时内接受治疗。主要观察指标主要结果是1年早期糖尿病视网膜病变研究(ETDRS)视敏度(VA)。重要的次要结局是主观视觉功能(25项国家眼科学院视觉功能问卷),变态评分(M-CHARTS)和主要的解剖学成功。结果在2012年8月至2016年5月之间招募了176例患者。在12个月时,PnR后的ETDRS VA比PPV后的ETDRS VA高4.9个字母(79.9±10.4个字母与75.0±15.2个字母; P = 0.024)。PnR组的平均ETDRS VA在3个月(78.4±12.3个字母对68.5±17.8个字母)和6个月(79.2±11.1个字母对68.6±17.2个字母)上也优于PPV组。美国国立眼科学院视觉功能问卷的25项综合评分在3个月和6个月时PnR得分更高。PnR组在12个月时的垂直变形评分高于PPV组(0.14±0.29 vs. 0.28±0.42; P = 0.026)。接受PnR的患者在12个月时的主要解剖学成功率为80.8%,而接受PPV的患者为93.2%(P = 0.045),分别达到98.7%和98.6%,达到了继发性解剖学成功。PPV组有晶状体眼的患者中有65%在12个月前接受了白内障手术,而PnR组为16%(P <0.001)。结论应当将气管性视网膜手术作为完成视网膜裂孔性视网膜脱离结果随机试验(PIVOT)募集标准的,满足气管性视网膜手术与玻璃体切除术的患者进行RRD的一线治疗。气动性视网膜手术可提供较高的视力,较少的垂直变形,
更新日期:2018-11-22
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