Dickersin Kay, Li Tianjing
Center for Clinical Trials and US Cochrane Center, Johns Hopkins University, Bloomberg School of Public Health, 615 North Wolfe Street, Mail Rm E6152, Baltimore, MD, USA, 21205.
Cochrane Database Syst Rev. 2015 Mar 12;2015(3):CD001538. doi: 10.1002/14651858.CD001538.pub4.
Nonarteritic anterior 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 NAION.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), PubMed (1948 to October 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (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. We last searched the electronic databases on 23 October 2014.
All randomized trials of surgical treatment of NAION were eligible for inclusion in this review.
From full-text copies of all reports from relevant trials, one author extracted data which were verified by another author. No data synthesis was required.
The one included trial, in which 258 participants were randomized, 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 3 or more lines compared with 42.6% of the careful follow-up group (unadjusted risk ratio (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 more often lost 3 or more lines of visual acuity in the study eye, although the increased risk was not statistically significant. At six months 18.9% in the surgery group had worsened visual acuity in the study eye 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 visual acuity in the study eye 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: The only eligible trial provided 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.
非动脉炎性前部缺血性视神经病变（NAION）的特征是眼部突然无痛性视力丧失，伴有视盘苍白肿胀。其病因不明，尚无医学疗法被证实对治疗该病有效。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造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或不治疗相比，对NAION患者的安全性和有效性。
我们检索了CENTRAL（其中包含Cochrane眼睛与视力组试验注册库）（2014年第10期）、Ovid MEDLINE、Ovid MEDLINE在研及其他未索引引文、Ovid MEDLINE日报、Ovid OLDMEDLINE（1946年1月至2014年10月）、EMBASE（1980年1月至2014年10月）、PubMed（1948年至2014年10月）、对照试验元注册库（mRCT）（www.controlled-trials.com）、ClinicalTrials.gov（www.clinicaltrials.gov）和世界卫生组织（WHO）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。我们最后一次检索电子数据库是在2014年10月23日。
所有NAION手术治疗随机试验均符合纳入本综述的条件。
从相关试验的所有报告全文副本中，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。
纳入的一项试验中，258名参与者被随机分组，该试验因无效而提前终止。在24个月报告时，六个月随访率为95.3%，24个月随访率为67.4%（174名参与者；89名仔细随访和85名手术）。没有证据表明手术对视力有好处。视力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%的患者视力提高了3行或更多，而仔细随访组为42.6%（未调整风险比（RR）0.75，95%置信区间（CI）0.54至1.04）。24个月时，手术组29.4%的患者视力有所改善，而仔细随访组为31.0%（未调整RR 0.95，95%CI 0.60至1.49）。接受手术的参与者研究眼中视力丧失3行或更多的情况更常见，尽管增加的风险无统计学意义。六个月时，手术组18.9%的患者研究眼视力恶化相比仔细随访组为14.8%（RR 1.28；95%CI 0.73至2.24）。24个月时，手术组20.0%的患者研究眼视力恶化相比仔细随访组为21.8%（RR 0.92；95%CI 0.51至·1.64）。接受手术的参与者经历了术中及术后不良事件，包括手术期间视网膜中央动脉阻塞和六个月时仅有光感视力（一名参与者）；以及手术后立即丧失光感和持续到12个月随访时的视力丧失（两名参与者）。在仔细随访组中，两名参与者在六个月随访时无光感；其中一名在12个月时改善为有光感。疼痛是手术组最常见的不良事件（手术组一周时为17%，仔细随访组为3%）。复视（重影）是其次最常见并发症（手术组一周时为8%，仔细随访组为1%）；三个月时两组有复视参与者比例无统计学显著差异。
唯一符合条件的试验未提供视神经减压手术对NAION有有益效果的证据。未来研究应集中于增进我们对NAION病因和预后的理解。新的治疗选择应在随机临床试验背景下进行检验。
