Service d'Ophtalmologie, Hôpital Lariboisière, AP-HP, Université Paris Diderot, Paris, France.
Ophthalmology. 2011 Jan;118(1):150-5. doi: 10.1016/j.ophtha.2010.04.040. Epub 2010 Oct 29.
To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position.
Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial.
Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months.
All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days.
The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications.
The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups.
The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
明确如果将面朝下体位改为小心避免仰卧位，小特发性黄斑裂孔（直径≤400μm）手术成功率是否会显著降低。
随机、对照、平行分组、开放标签、干预性、多中心临床试验。
69 例患者来自 6 家专门的玻璃体视网膜单位，随机分为 2 个平行组，术后随访 3 个月。
所有患者均接受经睫状体平坦部玻璃体切除术，剥离任何视网膜前膜，并填充 17% C₂F₆ 气体。然后，患者被随机建议严格面朝下体位 22 小时/24 小时或仅 10 天避免仰卧位。
主要观察指标为术后 3 个月的解剖闭合率。主要次要测量包括早期糖尿病性视网膜病变研究（ETDRS）视力、白内障进展和并发症发生率。
两组黄斑裂孔的平均大小约为 300μm。两组的闭合率均超过 90%：缓解体位组 34 只眼中有 32 只（91.4%），面朝下体位组 35 只眼中有 32 只（94.1%）（差异置信区间下限，-14.88%）。两组术后 3 个月的 ETDRS 评分分别增加了 10.23±14.64 个和 10.52±14.54 个字母。两组白内障进展和其他并发症发生率无显著差异。
如果将面朝下体位改为小心避免仰卧位，直径为 400μm 或更小的特发性黄斑裂孔手术成功率不会显著降低。对于这些黄斑裂孔，可以采用简化手术治疗，即不进行内界膜剥离和面朝下体位（仅避免仰卧位），其闭合率超过 90%，术后 3 个月平均视力提高超过 2 个 ETDRS 字母。
