Randazzo Alessandro, Nizzola Francesco, Rossetti Luca, Orzalesi Nicola, Vinciguerra Paolo
Department of Ophthalmology, Istituto Clinico Humanita-Rozzano, Modena, Italy.
J Cataract Refract Surg. 2005 Sep;31(9):1764-72. doi: 10.1016/j.jcrs.2005.02.042.
To evaluate the efficacy and safety of diluted aceclidine eyedrops in reducing night vision disturbances after refractive surgery.
Department of Ophthalmology, Istituto Clinico Humanitas, Rozzano-Milano, Italy.
This double-masked randomized clinical trial included 30 patients (60 eyes) with chronic night vision disturbance after refractive surgery. Patients were randomly allocated to receive (1) placebo, (2) aceclidine 0.016%, or (3) aceclidine 0.032%. Drugs were administered once or twice daily. Anterior segment, haze, uncorrected visual acuity, best corrected visual acuity, intraocular pressure, corneal maps, and scotopic pupil size were determined at baseline and at follow-up examinations (15 and 30 days after inclusion). Halos and double vision 4-step scales were built to determine subjective grading of night vision disturbance, and the root mean square (RMS) was calculated to determine objective changes in night vision disturbance.
The effect of diluted aceclidine started about 15 minutes after instillation and lasted for about 5 hours. No difference between the 2 dilutions could be found. Thirty-nine of 40 treated eyes showed a reduction in night vision disturbance. The mean reduction in halos and double vision grading was 1.42 +/- 0.5 (SD) and 1.14 +/- 0.4, respectively. A mean decrease in pupil size of 2.5 mm was measured. Thirty minutes after the instillation of diluted aceclidine, the topography-derived wavefront error showed a statistically significant reduction in RMS values (total, spherical, astigmatic, coma, and higher order), which was maintained for 5 hours. A transitory conjunctival hyperemia was the only side effect reported.
Diluted aceclidine seemed to be an effective and safe treatment for night vision disturbance following refractive surgery.
评估稀释的醋氮酰胺滴眼液在减轻屈光手术后夜间视力障碍方面的疗效和安全性。
意大利米兰罗扎诺市伊斯特托临床医院眼科。
这项双盲随机临床试验纳入了30例（60只眼）屈光手术后患有慢性夜间视力障碍的患者。患者被随机分配接受（1）安慰剂、（2）0.016%的醋氮酰胺或（3）0.032%的醋氮酰胺。药物每日给药1次或2次。在基线和随访检查时（纳入后15天和30天）测定眼前节、 haze、未矫正视力、最佳矫正视力、眼压、角膜地形图和暗视瞳孔大小。建立了光晕和复视4级量表来确定夜间视力障碍的主观分级，并计算均方根（RMS）以确定夜间视力障碍的客观变化。
稀释的醋氮酰胺滴眼后约15分钟开始起效，持续约5小时。两种稀释度之间未发现差异。40只治疗眼中的39只夜间视力障碍有所减轻。光晕和复视分级的平均降低分别为1.42±0.5（标准差）和1.14±0.4。测得瞳孔大小平均减小2.5mm。滴入稀释的醋氮酰胺30分钟后，地形图衍生的波前误差的RMS值在统计学上显著降低（总和、球面、散光、彗差和高阶），并持续5小时。报告的唯一副作用是短暂的结膜充血。
稀释的醋氮酰胺似乎是屈光手术后夜间视力障碍的一种有效且安全的治疗方法。
