Academic Unit of Ophthalmology, Australian National University, Canberra, Australia.
Academic Unit of Ophthalmology, Australian National University, Canberra, Australia.
Ophthalmology. 2016 May;123(5):1129-36. doi: 10.1016/j.ophtha.2015.12.039. Epub 2016 Feb 23.
To determine whether sulfur hexafluoride (SF6) gas is noninferior to longer-acting gases in macular hole surgery and whether withholding postoperative face-down positioning (FDP) is noninferior to FDP.
Registry-style, prospective, nonrandomized, observational cohort study.
Patients with idiopathic macular holes undergoing primary surgery.
Surgeons were invited to submit clinical details of all macular hole cases receiving surgery. Baseline demographic and clinical information were collected, as well as details of surgical intervention and postoperative posturing advice. Primary follow-up data were collected 3 months postoperatively.
Macular hole closure at 3 months. A noninferiority approach was used, with a noninferiority margin set at 5% decreased frequency of success.
A total of 2456 eyes of 2367 patients were included in the study. Outcomes were available in 94.9% of cases (2330/2456). The rate of macular hole closure was 95.0% (2214/2330). Sulfur hexafluoride gas was found to be noninferior to longer-acting gases (95% confidence interval [CI] for adjusted effect on success, -1.76 to +2.25), and noninferiority was demonstrated regardless of macular hole size. Although withholding FDP was found to be noninferior to FDP for the study population as a whole (95% CI for adjusted effect on success, -4.21 to +0.64), the result was inconclusive in holes >400 μm in diameter (95% CI, -9.31 to +1.04). Lack of internal limiting membrane (ILM) peel, increasing hole size, hole duration ≥9 months, increasing age, and 20-gauge surgery all were associated with lower odds of success. Vitreous attachment to the hole margin was not associated with outcome when corrected for hole size, and combined phacovitrectomy surgery was not observed to affect the odds of success in phakic eyes.
Sulfur hexafluoride gas tamponade was noninferior to longer-acting gases in the surgical management of macular hole. Withholding FDP was noninferior to FDP in holes ≤400 μm in diameter. In holes >400 μm in diameter, noninferiority of withholding FDP could not be concluded. We would advise caution if posturing is withheld in this group on the basis of the results of this study and of others.
确定六氟化硫（SF6）气体在黄斑裂孔手术中是否不劣于长效气体，以及是否不劣于术后面朝下体位（FDP）。
注册式、前瞻性、非随机、观察性队列研究。
接受原发性手术治疗的特发性黄斑裂孔患者。
邀请外科医生提交接受手术的所有黄斑裂孔病例的临床详细信息。收集基线人口统计学和临床信息，以及手术干预和术后体位建议的详细信息。术后 3 个月进行主要随访数据采集。
术后 3 个月黄斑裂孔闭合。采用非劣效性方法，非劣效性边界设定为成功率降低 5%。
共纳入 2367 例患者的 2456 只眼。94.9%（2330/2456）的病例获得了结局数据。黄斑裂孔闭合率为 95.0%（2214/2330）。SF6 气体被发现不劣于长效气体（调整后成功效果的 95%置信区间，-1.76 至+2.25），并且无论黄斑裂孔大小如何，均显示出非劣效性。尽管对于整个研究人群，不保留 FDP 与保留 FDP 相比被发现是非劣效的（调整后成功效果的 95%置信区间，-4.21 至+0.64），但对于直径>400μm 的孔，结果不确定（95%置信区间，-9.31 至+1.04）。缺乏内界膜（ILM）剥离、孔增大、孔持续时间≥9 个月、年龄增加和 20 号手术均与较低的成功率相关。当校正孔大小时，孔边缘的玻璃体附着与结果无关，并且在有晶状体眼中观察到联合晶状体玻璃体切除术手术不会影响成功的几率。
SF6 气体填塞在黄斑裂孔的手术治疗中不劣于长效气体。在直径≤400μm 的孔中，不保留 FDP 是非劣效的。在直径>400μm 的孔中，不能得出不保留 FDP 的非劣效性结论。如果基于本研究和其他研究的结果，建议在这一组中避免保持体位。
