Stolba Ulrike, Binder Susanne, Gruber Diego, Krebs Ilse, Aggermann Tina, Neumaier Beatrix
Department of Ophthalmology, Rudolf Foundation Clinic, Vienna, Austria.
Am J Ophthalmol. 2005 Aug;140(2):295-301. doi: 10.1016/j.ajo.2005.03.045.
To evaluate the potential benefit of vitrectomy in eyes with persistent diffuse macular edema.
Prospective randomized comparative clinical trial.
Eyes with diffuse diabetic macular edema for 6 to 18 months, an attached posterior hyaloid, and grid laser photocoagulation performed at least 4 months before were included. Patients were randomized either to a vitrectomy group or to a control group.
Evaluations of Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, reading vision, and retinal thickness were carried out at baseline and 1, 3, and 6 months after enrollment.
Fifty-six eyes (100%) were enrolled in this study. Twenty-five eyes (44.6%) were randomized into Gr I (vitrectomy group) and 31 eyes (55.4%) into Gr II (controls). Both groups were comparable in mean age (62.7 years and 63.9 years) and distribution of gender (one third male, two thirds female). ETDRS visual acuity showed a statistical significance in favor of Gr I at all time points (P = .035 to .005 Fisher's exact test). With Jaeger charts a significance for Gr I was found only at the 6-month examination (P = .01). With optical coherence tomography, the different behavior of retinal thickness changes in both groups during follow-up was statistically significant; P values were <.0001 for month 1, 3, and 6, preferring Gr I.
We provide evidence that vitrectomy with internal limiting membrane peeling is superior to observation alone in eyes with persistent diffuse diabetic macular edema for 6 to 18 months. Longer follow-up periods and larger series might be needed to confirm these results and gain additional information.
评估玻璃体切除术对持续性弥漫性黄斑水肿患者的潜在益处。
前瞻性随机对照临床试验。
纳入患有弥漫性糖尿病性黄斑水肿6至18个月、后玻璃体附着且至少在4个月前已进行格栅样激光光凝的患者。患者被随机分为玻璃体切除组或对照组。
在基线以及入组后1、3和6个月对糖尿病视网膜病变早期治疗研究（ETDRS）视力、阅读视力和视网膜厚度进行评估。
本研究共纳入56只眼（100%）。25只眼（44.6%）被随机分为I组（玻璃体切除组），31只眼（55.4%）被分为II组（对照组）。两组在平均年龄（62.7岁和63.9岁）和性别分布（三分之一为男性，三分之二为女性）方面具有可比性。ETDRS视力在所有时间点均显示I组具有统计学意义（P = 0.035至0.005，Fisher精确检验）。使用耶格视力表，仅在6个月检查时发现I组具有统计学意义（P = 0.01）。通过光学相干断层扫描，两组在随访期间视网膜厚度变化的不同表现具有统计学意义；第1、3和6个月的P值均<0.0001，I组更具优势。
我们提供的证据表明，对于患有持续性弥漫性糖尿病性黄斑水肿6至18个月的患者，玻璃体切除联合内界膜剥除术优于单纯观察。可能需要更长的随访期和更大的样本量来证实这些结果并获取更多信息。
