JAMA. 1995 Feb 22;273(8):625-32.
To assess the safety and efficacy of optic nerve decompression surgery compared with careful follow-up alone in patients with nonarteritic anterior ischemic optic neuropathy (NAION).
The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a randomized, single-masked, multicenter trial.
Twenty-five US clinical centers.
The IONDT ceased recruitment on October 20, 1994, on the recommendation of its Data and Safety Monitoring Committee. The preliminary results presented herein are based on data as of September 8, 1994, from 244 patients with NAION and visual acuity of 20/64 or worse. One hundred twenty-five patients had been randomized to careful follow-up, and 119 had been randomized to surgery, with 91 and 95, respectively, having completed 6 months of follow-up.
Patients in the surgery group received optic nerve decompression surgery and follow-up ophthalmologic examinations; those in the careful follow-up group received ophthalmologic examinations at the same times as the surgery group.
Gain or loss of three or more lines of visual acuity on the New York Lighthouse chart at 6 months after randomization, as measured by a technician masked to treatment assignment.
Patients assigned to surgery did no better when compared with patients assigned to careful follow-up regarding improved visual acuity of three or more lines at 6 months: 32.6% of the surgery group improved compared with 42.7% of the careful follow-up group. The odds ratio (OR) for three or more lines better, adjusted for baseline visual acuity and diabetes, was 0.74 (95% confidence interval [CI], 0.39 to 1.38). Patients receiving surgery had a significantly greater risk of losing three or more lines of vision at 6 months: 23.9% in the surgery group worsened compared with 12.4% in the careful follow-up group. The 6-month adjusted OR for three or more lines worse was 1.96 (95% CI, 0.87 to 4.41). No difference in treatment effect was observed between patients with progressive NAION and all others.
Results from the IONDT indicate that optic nerve decompression surgery for NAION is not effective, may be harmful, and should be abandoned. The spontaneous improvement rate is better than previously reported.
评估非动脉炎性前部缺血性视神经病变（NAION）患者中，视神经减压手术相较于单纯密切随访的安全性和有效性。
缺血性视神经病变减压试验（IONDT）是一项随机、单盲、多中心试验。
美国25个临床中心。
根据数据与安全监测委员会的建议，IONDT于1994年10月20日停止招募。本文呈现的初步结果基于截至1994年9月8日的数据，来自244例视力为20/64或更差的NAION患者。125例患者被随机分配至密切随访组，119例被随机分配至手术组，分别有91例和95例完成了6个月的随访。
手术组患者接受视神经减压手术及后续眼科检查；密切随访组患者在与手术组相同的时间接受眼科检查。
由对治疗分配不知情的技术人员测量，随机分组后6个月时纽约灯塔视力表上视力提高或降低3行及以上。
在6个月时视力提高3行及以上方面，手术组患者与密切随访组患者相比并无更好表现：手术组32.6%的患者视力改善，而密切随访组为42.7%。在根据基线视力和糖尿病进行调整后，视力提高3行及以上的优势比（OR）为0.74（95%置信区间[CI]，0.39至1.38）。接受手术的患者在6个月时视力降低3行及以上的风险显著更高：手术组23.9%的患者视力恶化，而密切随访组为12.4%。在6个月时视力降低3行及以上的调整后OR为1.96（95%CI，0.87至4.41）。进展性NAION患者与其他所有患者之间未观察到治疗效果的差异。
IONDT的结果表明，NAION的视神经减压手术无效，可能有害，应予以摒弃。自发改善率优于先前报道。
