Dickersin Kay, Manheimer Eric, Li Tianjing
Center for Clinical Trials and US Cochrane Center, Johns Hopkins University, Bloomberg School ofPublic Health, 615 North Wolfe Street, Mail Rm W5010, Baltimore, MD, 21205, USA.
Cochrane Database Syst Rev. 2012 Jan 18;1:CD001538. doi: 10.1002/14651858.CD001538.pub3.
Nonarteritic ischemic optic neuropathy (NAION) is characterized by sudden and painless loss of vision in the eye, accompanied by pallid swelling of the optic disc. Its etiology is unknown and no medical therapy has been proven effective in treating this condition. Optic nerve decompression surgery, a proposed treatment for NAION, involves making two or more slits or a window in the tissue surrounding the optic nerve, thereby allowing cerebrospinal fluid to escape, and theoretically reducing the pressure surrounding the optic nerve.
The objective of this review was to assess the safety and efficacy of surgery compared with other treatment or no treatment in people with nonarteritic ischemic optic neuropathy.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 11), MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 19 November 2011.
All randomized trials of surgical treatment of NAION were eligible for inclusion in this review.
We obtained full copies of all potentially relevant articles. One author extracted data which was verified by another author. No data synthesis was required.
The one included trial randomized 258 participants and was stopped early for futility. At the time of the 24-month report the follow-up rate was 95.3% for six months and 67.4% for 24 months (174 participants; 89 careful follow up and 85 surgery). There was no evidence of a benefit of surgery on visual acuity. Measurements of visual acuity and visual fields were performed by a technician masked to the treatment received. At six months 32.0% of the surgery group had improved visual acuity by three or more lines compared with 42.6% of the careful follow up group (unadjusted relative risk (RR) 0.75, 95% confidence interval (CI) 0.54 to 1.04). At 24 months 29.4% of the surgery group had improved compared with 31.0% of the careful follow up group (unadjusted RR 0.95, 95% CI 0.60 to 1.49). Participants who underwent surgery had a greater risk of losing three or more lines of vision, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened compared with 14.8% in the careful follow up group (RR 1.28; 95% CI 0.73 to 2.24). At 24 months 20.0% in the surgery group had worsened compared with 21.8% in the careful follow up group (RR 0.92; 95% CI 0.51 to 1.64). Participants who received surgery experienced both intraoperative and postoperative adverse events, including central retinal artery occlusion during surgery and light perception vision at six months (one participant); and immediate loss of light perception following surgery and loss of vision that persisted to the 12-month visit (two participants). In the careful follow-up group, two participants had no light perception at the six-month follow-up visit; one of these had improved to light perception at 12 months. Pain was the most common adverse event in the surgery group (17% in surgery group versus 3% in the careful follow-up group at one week). Diplopia (double-vision) was the next most common complication (8% in the surgery group versus 1% in the careful follow-up group at one week); at three months there was no statistically significant difference in proportion of participants with diplopia between the two groups.
AUTHORS' CONCLUSIONS: Results from the single trial indicate no evidence of a beneficial effect of optic nerve decompression surgery for NAION. Future research should focus on increasing our understanding of the etiology and prognosis of NAION. New treatment options should be examined in the context of randomized clinical trials.
非动脉炎性缺血性视神经病变(NAION)的特征是眼部突然无痛性视力丧失,并伴有视盘苍白肿胀。其病因不明,尚无医学疗法被证明对治疗这种疾病有效。视神经减压手术是一种针对NAION的提议治疗方法,包括在视神经周围组织上制作两个或更多切口或一个窗口,从而使脑脊液流出,并理论上降低视神经周围的压力。
本综述的目的是评估手术与其他治疗方法或不治疗相比,对非动脉炎性缺血性视神经病变患者的安全性和有效性。
我们检索了CENTRAL(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2011年第11期)、MEDLINE(1950年1月至2011年11月)、EMBASE(1980年1月至2011年11月)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(http://clinicaltrials.gov)和世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。电子检索试验时没有日期或语言限制。电子数据库最后一次检索时间为2011年11月19日。
所有NAION手术治疗的随机试验均符合纳入本综述的条件。
我们获取了所有潜在相关文章的完整副本。由一位作者提取数据,另一位作者进行核实。无需进行数据合成。
纳入的一项试验将258名参与者随机分组,因无效而提前终止试验。在24个月报告时,六个月的随访率为95.3%,24个月的随访率为67.4%(174名参与者;89名仔细随访和85名手术治疗)。没有证据表明手术对视敏度有好处。视敏度和视野测量由对所接受治疗不知情的技术人员进行。六个月时,手术组32.0%的患者视敏度提高了三行或更多行,而仔细随访组为4