Department of Ophthalmology, Stavanger University Hospital, Stavanger, Norway; Department of Clinical Medicine, Section of Ophthalmology, University of Bergen, Bergen, Norway.
Department of Clinical Medicine, Section of Ophthalmology, University of Bergen, Bergen, Norway; Department of Ophthalmology, Haukeland University Hospital, Bergen, Norway.
Ophthalmol Retina. 2022 Sep;6(9):828-834. doi: 10.1016/j.oret.2022.04.003. Epub 2022 Apr 7.
To investigate whether air tamponade is noninferior to sulfur hexafluoride (SF) gas tamponade for small (≤ 250 μm) and medium-sized (> 250 μm and ≤ 400 μm) macular holes (MHs).
Multicenter, randomized controlled, noninferiority trial.
Patients aged ≥ 18 years undergoing surgery for primary MHs of ≤ 400 μm in diameter.
The patients in both groups underwent conventional pars plana vitrectomy with peeling of the internal limiting membrane. At the end of the surgery, the patients were randomized to receive either air or SF gas tamponades, stratified by MH size. Postoperatively, the patients followed a nonsupine positioning regimen for 3 days.
The primary end point was the MH closure rate after a single surgery, confirmed by OCT after 2 to 8 weeks. The noninferiority margin was set at a 10-percentage-point difference in the closure rate.
In total, 150 patients were included (75 in each group). In the intention-to-treat (ITT) analysis, 65 of 75 patients in the air group achieved primary closure. All 75 MHs in the SF group closed after a single surgery. Six patients were excluded from the per-protocol (PP) analysis. In the PP analysis, 63 of 70 patients in the air group and all 74 patients in the SF group achieved MH closure after a single surgery, resulting in closure rates of 90% (95% confidence interval [CI], 79.9%-95.5%) and 100% (95% CI, 93.9%-100%), respectively. For the difference in closure rates, the lower bound of a 2-sided 95% CI exceeded the noninferiority margin of 10% in both ITT and PP analyses. In the subgroups of small MHs, all 20 patients in the air group and all 28 patients in the SF group achieved primary closure.
This prospective randomized controlled trial proved that air tamponade is inferior to SF tamponade for MHs of ≤ 400 μm in diameter.
研究空气填充是否不如六氟化硫（SF）气体填充对于小（≤250μm）和中等大小（＞250μm 且≤400μm）黄斑裂孔（MH）有效。
多中心、随机对照、非劣效性试验。
接受手术治疗原发性直径≤400μm MH 的年龄≥18 岁的患者。
两组患者均接受传统经睫状体平坦部玻璃体切除术联合内界膜剥除术。手术结束时，患者根据 MH 大小随机分为接受空气或 SF 气体填充组。术后，患者遵循非仰卧位体位方案 3 天。
主要终点是手术后 2 至 8 周 OCT 证实的单次手术后 MH 闭合率。非劣效性边界设定为闭合率相差 10%。
共纳入 150 例患者（每组 75 例）。在意向治疗（ITT）分析中，空气组 75 例患者中有 65 例达到主要闭合。SF 组的所有 75 个 MH 在单次手术后均闭合。有 6 例患者被排除在符合方案（PP）分析之外。在 PP 分析中，空气组的 70 例患者中有 63 例和 SF 组的 74 例患者在单次手术后均达到 MH 闭合，闭合率分别为 90%（95%置信区间[CI]，79.9%-95.5%）和 100%（95% CI，93.9%-100%）。对于闭合率的差异，双侧 95%CI 的下限在 ITT 和 PP 分析中均超过了 10%的非劣效性边界。在小 MH 亚组中，空气组的 20 例患者和 SF 组的 28 例患者均达到了主要闭合。
这项前瞻性随机对照试验证明，对于直径≤400μm 的 MH，空气填充不如 SF 填充有效。
