Fung W E
Ophthalmology. 1985 Aug;92(8):1102-11. doi: 10.1016/s0161-6420(85)33917-9.
A five-year (1979-1984) prospective, randomized, controlled, collaborative study was performed by 27 experienced vitrectomy surgeons in 15 medical centers on 136 surgically aphakic eyes without lens implants but with vitreous adherent to the corneoscleral wound and with chronic aphakic cystoid macular edema (ACME). One hundred fifteen eyes completed the entire course of investigation. The purpose of the study was twofold: to determine the effectiveness of vitrectomy in eliminating established ACME and to determine the natural history of this condition. Following criteria contained within the study protocol, 68 eyes were randomized to surgery (RAN-S) or control (RAN-C), and 47 eyes were observed in the long-term observation group (LTO). Twenty-one eyes were eliminated from the investigation for reasons stated in the text. The RAN-S group proved to have a significantly better visual course than the RAN-C group (P = less than 0.01). An analysis of the LTO group revealed that if central vision did not decline to a level of 20/80 or worse, 27% of the eyes had a chance of spontaneously improving to a level of 20/50 or better. However, if central vision declines to or beyond this point, spontaneous visual improvement to 20/50 or better only occurred in 8% of eyes. Also reported are other important clinical findings such as the role of systemic diseases in ACME, the incidence of vitreous traction on the macula, prognostic value of pre-surgical medical therapy, a comparison of limbal versus pars plana surgical approach, the timing of surgery, and the effectiveness of fluorescein angiography as an objective monitor of visual function.
15个医学中心的27位经验丰富的玻璃体切割手术医生对136只无晶状体植入物、玻璃体粘连于角膜巩膜伤口且患有慢性无晶状体性黄斑囊样水肿(ACME)的手术性无晶状体眼进行了一项为期五年(1979 - 1984年)的前瞻性、随机、对照、协作研究。115只眼完成了整个研究过程。该研究有两个目的:确定玻璃体切割术消除已形成的ACME的有效性以及确定这种疾病的自然病程。按照研究方案中的标准,68只眼被随机分为手术组(RAN - S)或对照组(RAN - C),47只眼被纳入长期观察组(LTO)。另有21只眼因文中所述原因被排除在研究之外。结果证明,RAN - S组的视力转归明显优于RAN - C组(P<0.01)。对LTO组的分析显示,如果中心视力未下降到20/80或更差的水平,27%的眼睛有机会自发改善到20/50或更好的水平。然而,如果中心视力下降到或低于这个水平,只有8%的眼睛能自发改善到20/50或更好。文中还报告了其他重要的临床发现,如全身性疾病在ACME中的作用、黄斑部玻璃体牵引的发生率、术前药物治疗的预后价值、角膜缘与睫状体扁平部手术入路的比较、手术时机以及荧光素血管造影作为视觉功能客观监测指标的有效性。