Blum Marcus, Kunert Kathleen, Gille Annika, Sekundo Walter
Department of Ophthalmology, Helios Hospital, Erfurt, Germany.
J Refract Surg. 2009 Apr;25(4):350-6. doi: 10.3928/1081597X-20090401-01.
To assess the efficacy, safety, and predictability of the VisuMax femtosecond laser (Carl Zeiss Meditec).
In a prospective, multicenter clinical trial, 32 eyes of 17 patients underwent LASIK and flap creation with the VisuMax femtosecond laser and ablation with the MEL 80 excimer laser (Carl Zeiss Meditec). Mean patient age was 35 years (range: 23 to 52 years). Mean preoperative spherical equivalent refraction was -4.04 +/- 1.39 diopters (D) (range: -1.50 to -7.25 D), and the planned flap thickness was 110, 120, 140, and 150 microm.
At the 3-month postoperative examination, all eyes had best spectacle-corrected visual acuity of 20/25 and uncorrected visual acuity (UCVA) of 20/40; 91% of eyes reached UCVA of 20/20 or better. Ninety-four percent of eyes were within +/- 0.50 D of the planned correction. Complications were limited to one case of suction loss, and no other adverse events were noted at 3 months. The flaps were planar and the mean achieved central flap thickness was 118 +/-9.2 microm for an attempted thickness of 120 microm.
The investigators achieved LASIK outcomes exceeding the US Food and Drug Administration guidelines for refractive procedures in this series of myopic eyes using the VisuMax femtosecond laser and MEL 80 excimer laser. The curved contact lens of the applanation glass combined with low suction permitted continuous fixation during treatment.
评估VisuMax飞秒激光(卡尔蔡司医疗技术公司)的疗效、安全性和可预测性。
在一项前瞻性多中心临床试验中,17例患者的32只眼睛接受了使用VisuMax飞秒激光制作角膜瓣并使用MEL 80准分子激光(卡尔蔡司医疗技术公司)进行切削的准分子原位角膜磨镶术(LASIK)。患者平均年龄为35岁(范围:23至52岁)。术前平均等效球镜度为-4.04±1.39屈光度(D)(范围:-1.50至-7.25 D),计划的角膜瓣厚度为110、120、140和150微米。
术后3个月检查时,所有眼睛的最佳矫正视力均为20/25,未矫正视力(UCVA)为20/40;91%的眼睛UCVA达到20/20或更好。94%的眼睛屈光矫正度数在计划矫正度数的±0.50 D范围内。并发症仅限于1例负压吸引失败,3个月时未发现其他不良事件。角膜瓣平整,对于计划厚度为120微米的情况,平均实际中央角膜瓣厚度为118±9.2微米。
在这一系列近视眼中,研究人员使用VisuMax飞秒激光和MEL 80准分子激光取得了超出美国食品药品监督管理局屈光手术指南的LASIK手术效果。压平式玻璃的曲面接触镜与低负压吸引相结合,使得治疗过程中能持续固定眼球。