de Bustros S
Department of Ophthalmology, Rush Medical College, Chicago, Illinois.
Ophthalmology. 1994 Jun;101(6):1055-9; discussion 1060. doi: 10.1016/s0161-6420(94)31218-8.
The purpose of this study is to assess the benefit of vitreous surgery in preventing full-thickness macular holes in patients with impending (stage 1) macular holes.
A prospective randomized multicenter clinical trial was conducted on patients with full-thickness macular holes in their first eye (stage 3 or 4) and signs and symptoms of stage 1 macular holes in their fellow eye (study eye). The study eye was randomized to vitreous surgery or observation. Outcome was assessed by standardized measurement of visual acuity, detailed clinical examination, fundus photographs, and fluorescein angiography.
A full-thickness macular hole developed in 10 (37%) of 27 patients in the vitrectomy group compared with 14 (40%) of 35 patients randomized to observation (P = 0.81). This difference of 3% has a 95% confidence interval of (-21%, 27%).
The study was terminated because of low recruitment. The authors were unable to prove (or disprove) the benefit of vitreous surgery in patients with stage 1 macular holes. The authors can state, however, that should a beneficial effect from vitrectomy exist, it would probably be minimal. Considering the cost and morbidity of vitreous surgery, a conservative approach for stage 1 macular hole might be appropriate.
本研究旨在评估玻璃体手术对预防即将发生（1期）黄斑裂孔患者出现全层黄斑裂孔的益处。
对第一眼患有全层黄斑裂孔（3期或4期）且对侧眼（研究眼）有1期黄斑裂孔体征和症状的患者进行了一项前瞻性随机多中心临床试验。研究眼被随机分为接受玻璃体手术或观察。通过标准化视力测量、详细临床检查、眼底照片和荧光素血管造影来评估结果。
玻璃体切除组27例患者中有10例（37%）出现了全层黄斑裂孔，而随机接受观察的35例患者中有14例（40%）出现了全层黄斑裂孔（P = 0.81）。3%的差异其95%置信区间为（-21%，27%）。
由于入组率低，该研究提前终止。作者无法证明（或反驳）玻璃体手术对1期黄斑裂孔患者的益处。然而，作者可以指出的是，即使玻璃体切除术存在有益效果，可能也非常微小。考虑到玻璃体手术的成本和发病率，对1期黄斑裂孔采取保守治疗方法可能是合适的。
