Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair The PostRD Randomized Clinical Trial
Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair The PostRD Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2020.0997
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发表时间：
2020-06-01
影响因子：
8.1
通讯作者：
Charteris, David G.
中科院分区：
文献类型：
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作者：
Casswell, Edward J.;Yorston, David;Charteris, David G.
重要性 对于涉及黄斑的视网膜脱离 (RD) 修复后患者的最佳定位方案缺乏共识。 目的 评估面朝下定位与支撑断裂定位对涉及黄斑的 RD 修复后视网膜移位和扭曲的影响。 设计、环境和参与者 从 5 月份开始，在多中心三级转诊机构进行了一项为期 6 个月的单盲随机临床试验。 2016年12月16日至2018年5月1日。纳入标准为中央凹累及孔源性RD； 14天内中心视力丧失；在局部麻醉下接受初次玻璃体切除术和气体手术的患者；患者能够提供书面知情同意书； 18 岁及以上。分析是按照修改后的意向治疗原则进行的，经历黄斑重新脱离或附着失败的患者被排除在分析之外。 干预措施 参与者以 1:1 的比例随机分配，接受术后 24 小时内面朝下体位或支撑断裂体位。未监测定位依从性。主要结果和措施术后6个月自发荧光成像显示视网膜移位的患者比例。次要结局包括 2 个月时移位的患者比例； 2 个月和 6 个月时的位移幅度；纠正早期治疗糖尿病视网膜病变研究视力；客观失真分数；以及 6 个月时的生活质量问卷评分。 结果 在 262 名随机患者中，分析了 239 名患者（171 名男性 [71.5%]；平均 [SD] 年龄，60.8 [9.8] 岁）。 6 个月时，面朝下定位组的 100 人中有 42 人 (42%) 检测到视网膜移位，而支撑断裂定位组的 103 人中有 58 人 (56%) 检测到视网膜移位（比值比，1.77；95%CI，1.01-3.11；P = .04）。面朝下组的位移程度较低。各组在 2 个月和 6 个月时的矫正视力（面朝下，74 个字母与支持突破，75 个字母）、客观 D 图表畸变评分（范围：0，无畸变至 41.6，严重畸变；面朝下为 4.5，支持突破为 4.2）以及生活质量评分（面朝下 89.3 与支持突破 89.0）相似。两组的视网膜再脱离率相似（面朝下组，12.2%，支持折断组，13.7%）。与支撑断裂定位组相比，面朝下定位组的视网膜褶皱较少见（分别为 5.3% 和 13.5%；比值比，2.8；95% CI，1.2-7.4；P = 0.03）。与面朝下定位组相比，支持打破组的双眼复视更为常见（分别为 7.6% 和 1.5%；比值比，5.3；95% CI，1.3-24.6；P = .03）。位移幅度与较差的视力 (r = -0.5; P < .001) 和畸变 (r = 0.28; P = .008) 相关。 结论和相关性 在这项研究中，研究结果表明，面朝下的姿势与黄斑相关 RD 修复术后视网膜移位率和幅度的降低以及双眼复视的减少相关。未发现与视力或术后畸变相关。
IMPORTANCE A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair.OBJECTIVE To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair.DESIGN, SETTING, AND PARTICIPANTS A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis.INTERVENTIONS Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored.MAIN OUTCOMES AND MEASURES The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months.RESULTS Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008).CONCLUSIONS AND RELEVANCE In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion.