Pasu Saruban, Bell Lauren, Zenasni Zohra, Lanz Doris, Simmonds Irene A, Thompson Ann, Yorston David, Laidlaw D Alistair H, Bunce Catey, Hooper Richard, Bainbridge James W B
National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.
Moorfields Eye Hospital NHS Foundation Trust, London, England.
JAMA Ophthalmol. 2020 Jul 1;138(7):725-730. doi: 10.1001/jamaophthalmol.2020.0987.
The value of facedown positioning following surgery for large full-thickness macular holes is unknown.
To determine whether advice to position facedown postoperatively improves the outcome for large macular holes.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months' follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract.
Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days.
The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25.
A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was observed in 90 (85.6%) who were advised to position face forward and 88 (95.5%) advised to position facedown (adjusted odds ratio, 3.15; 95% CI, 0.87-11.41; P = .08). The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR (equivalent to 1 Snellen line) in the face-forward group and 0.57 (0.42) logMAR (equivalent to 3 Snellen lines) in the facedown group (adjusted mean difference, 0.22 [95 % CI, 0.05-0.38]; equivalent to 2 Snellen lines); 95% CI, 0.05-0.38; P = .01). The median National Eye Institute Visual Function Questionnaire 25 score was 89 (interquartile range, 76-94) in the facedown group and 87 (interquartile range, 73-93) in the face-forward group (mean [SD] change on a logistic scale, 0.08 [0.26] face forward and 0.11 [0.25] facedown; adjusted mean [SD] difference on a logistic scale, 0.02; 95% CI, -0.03 to 0.07; P = .41).
The results do not prove that facedown positioning following surgery is more likely to close large macular holes compared with facing forward but do support the possibility that visual acuity outcomes may be superior.
Isrctn.org Identifier: 12410596.
对于大型全层黄斑裂孔手术后采用俯卧位的价值尚不清楚。
确定术后建议采用俯卧位是否能改善大型黄斑裂孔的治疗效果。
设计、地点和参与者：这项随机、平行组优效性试验在英国的9个地点进行，随机比例为1:1，并按地点分层，随访3个月。纳入了特发性全层黄斑裂孔患者，其最小线性直径至少为400μm，病程少于12个月。所有参与者均接受了玻璃体切除术，包括剥除内界膜并注入全氟丙烷（14%）气体，部分患者同时进行了白内障手术。
术后，参与者被随机建议每天俯卧位或正位8小时，持续5天。
主要结局是术后3个月通过盲态光学相干断层扫描评估确定的黄斑裂孔闭合情况。3个月时的次要结局指标包括视力、参与者报告的体位体验以及通过国立眼科研究所视觉功能问卷25评估的生活质量。
共有185名参与者（45名男性[24.3%]；156名白人[84.3%]；9名黑人[4.9%]；10名亚洲人[5.4%]；年龄中位数69岁[四分位间距，64 - 73岁]）被随机分组。建议正位的参与者中有90名（85.6%）黄斑裂孔闭合，建议俯卧位的参与者中有88名（95.5%）黄斑裂孔闭合（调整后的优势比为3.15；95%置信区间，0.87 - 11.41；P = 0.08）。3个月时，正位组最佳矫正视力的平均（标准差）改善为0.34（0.69）logMAR（相当于1行斯内伦视力表），俯卧位组为0.57（0.42）logMAR（相当于3行斯内伦视力表）（调整后的平均差值为0.22[95%置信区间，0.05 - 0.38]；相当于2行斯内伦视力表）；95%置信区间，0.05 - 0.38；P = 0.01）。国立眼科研究所视觉功能问卷25的中位数得分在俯卧位组为89（四分位间距，76 - 94），正位组为87（四分位间距，73 - 93）（逻辑尺度上的平均[标准差]变化，正位为0.08[0.26]，俯卧位为0.11[0.25]；逻辑尺度上调整后的平均[标准差]差值为0.02；95%置信区间， - 0.03至0.07；P = 0.41）。
结果并未证明与正位相比，术后俯卧位更有可能闭合大型黄斑裂孔，但确实支持视力结果可能更好的可能性。
Isrctn.org标识符：12410596。
