Arch Ophthalmol. 1996 Nov;114(11):1366-74. doi: 10.1001/archopht.1996.01100140566007.
To describe the baseline clinical characteristics of patients in the Ischemic Optic Neuropathy Decompression Trial (IONDT).
The IONDT is a single-masked, multicenter, randomized clinical trial.
Twenty-five US clinical centers.
Eligibility criteria for randomization to either optic nerve sheath decompression surgery or careful follow-up included a diagnosis of acute unilateral nonarteritic anterior ischemic optic neuropathy (NAION), a visual acuity of 20/64 or worse and better than no light perception, and an age of 50 years or older. Patients who were eligible except for having visual acuity better than 20/64 were not randomized, but were followed up.
Each patient underwent a standardized history and examination by certified study personnel within 14 days of the onset of symptoms. Masked personnel performed outcome measurements.
Of 420 patients with NAION, 258 were randomized, and 162 were not randomized and are being followed up. Sixty-two percent of the patients were men and 95% were white. The mean +/- SD age at onset was 66.0 +/- 8.7 years. Hypertension was reported in 47% of the patients in the IONDT, and 24% of the patients had diabetes mellitus. Forty-two percent of the patients recalled the onset of visual symptoms to be within 2 hours of awakening. Initial visual acuities in the study eye ranged from 20/20 or better to light perception, with 49% of the patients seeing better than 20/64 and 34% of the patients seeing 20/200 or worse. The mean Westergren sedimentation rate was 18.4 mm/h, with 9% of the patients having a rate greater than 40 mm/h. The nonrandomized patients (visual acuity better than 20/64) were younger, 72% were male, and they had a lower prevalence of hypertension and diabetes mellitus.
Although our baseline findings are derived from a selected population of patients with NAION who were eligible for the IONDT, they provide the first description of NAION from a large prospective study that used a standard definition of NAION and only included patients who were identified within 2 weeks of the onset of symptoms.
描述缺血性视神经病变减压试验(IONDT)中患者的基线临床特征。
IONDT是一项单盲、多中心、随机临床试验。
美国25个临床中心。
随机分为视神经鞘减压手术组或密切随访组的入选标准包括急性单侧非动脉性前部缺血性视神经病变(NAION)的诊断、视力为20/64或更差且优于无光感,以及年龄在50岁或以上。除视力优于20/64外符合入选标准的患者未进行随机分组,而是接受随访。
每位患者在症状发作后14天内由经过认证的研究人员进行标准化病史采集和检查。盲法人员进行结局测量。
在420例NAION患者中,258例被随机分组,162例未被随机分组并正在接受随访。62%的患者为男性,95%为白人。发病时的平均年龄±标准差为66.0±8.7岁。IONDT中47%的患者报告有高血压,24%的患者患有糖尿病。42%的患者回忆起视觉症状发作在醒来后2小时内。研究眼的初始视力范围从20/20或更好到光感,49%的患者视力优于20/64,34%的患者视力为20/200或更差。平均魏氏血沉率为18.4mm/h,9%的患者血沉率大于40mm/h。未随机分组的患者(视力优于20/64)更年轻,72%为男性,高血压和糖尿病的患病率较低。
尽管我们的基线研究结果来自符合IONDT入选标准的特定NAION患者群体,但它们首次对NAION进行了描述,该描述来自一项大型前瞻性研究,该研究使用了NAION的标准定义,且仅纳入了症状发作后2周内确诊的患者。