Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.
Tennent Institute of Ophthalmology, Gartnavel Hospital, Glasgow, United Kingdom.
JAMA Ophthalmol. 2020 Jun 1;138(6):634-642. doi: 10.1001/jamaophthalmol.2020.0997.
A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair.
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.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT02748538.
重要性:在涉及黄斑受累视网膜脱离(RD)修复后的患者最佳体位方案方面,目前尚存在共识缺失。
目的:评估面朝下体位与支持间断体位对黄斑受累 RD 修复后视网膜移位和变形的影响。
设计、设置和参与者:这是一项前瞻性、6 个月、单盲、随机临床试验,于 2016 年 5 月 16 日至 2018 年 5 月 1 日在多中心三级转诊机构进行。纳入标准为:黄斑受累的孔源性 RD;发病后 14 天内中央视力丧失;接受局部麻醉下玻璃体切除术和气体手术的患者;能够书面知情同意的患者;年龄 18 岁及以上。根据改良意向治疗原则进行分析,将再次脱离或黄斑未贴附的患者排除在分析之外。
干预措施:参与者被随机分为 1:1 接受面朝下体位或支持间断体位 24 小时。未监测体位依从性。
主要结局和测量指标:术后 6 个月时自动荧光成像上视网膜移位的患者比例。次要结局包括术后 2 个月时的移位比例;2 个月和 6 个月时的位移幅度;矫正后的早期治疗糖尿病视网膜病变研究视力;客观失真评分;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,有 239 名(171 名男性[71.5%];平均[标准差]年龄 60.8[9.8]岁)被纳入分析。在 6 个月时,面朝下组 100 名患者中有 42 名(42%)检测到视网膜移位,而支持间断组 103 名患者中有 58 名(56%)(优势比,1.77;95%置信区间,1.01-3.11;P=0.04)。面朝下组的移位程度较低。两组间矫正视力(面朝下组 74 个字母 vs 支持间断组 75 个字母)、客观 D 图表失真评分(范围:0 无失真至 41.6 严重失真;面朝下组 4.5 vs 支持间断组 4.2)和生活质量评分(面朝下组 89.3 vs 支持间断组 89.0)在 2 个月和 6 个月时相似。两组间视网膜再脱离率相似(面朝下组 12.2%和支持间断组 13.7%)。面朝下组视网膜褶皱较支持间断组少见(5.3% vs 13.5%,分别;优势比,2.8;95%置信区间,1.2-7.4;P=0.03)。与面朝下体位组相比,支持间断体位组双眼复视更常见(7.6% vs 1.5%,分别;优势比,5.3;95%置信区间,1.3-24.6;P=0.03)。视网膜位移幅度与视力较差(r=-0.5;P<0.001)和变形(r=0.28;P=0.008)相关。
结论和相关性:在这项研究中,结果表明,面朝下体位与黄斑受累 RD 修复后术后视网膜移位的发生率和幅度降低以及双眼复视减少相关。与术后视力或变形无相关性。
试验注册:ClinicalTrials.gov 标识符:NCT02748538。