Singapore National Eye Centre, 11 Third Hospital Avenue, Singapore.
Ophthalmology. 2010 Jun;117(6):1236-1244.e1. doi: 10.1016/j.ophtha.2009.10.042. Epub 2010 Feb 13.
This study evaluates the efficacy, predictability and safety of LASIK surgery as a treatment for myopia performed as part of a large-scale, prospective clinical audit spanning 10 years in an Asian study population and to evaluate the outcomes and trends.
Prospective, nonrandomized, single-center, multisurgeon study.
We included 37,932 eyes of 19,753 patients that underwent myopic LASIK at the Singapore National Eye Centre between 1998 and 2007.
All eyes underwent LASIK as a treatment for myopia. Pre- and postoperative refractions, uncorrected visual acuity (UCVA), and best-corrected visual acuity (BCVA) were documented.
Safety, efficacy, refractive predictability, treatment trends, retreatment rates, and complications for mild, moderate, and high myopia according to spherical equivalence (SE) of less than -5.00 diopters (D), -5.00 D or more to less than -10.0 D, and -10.00 D or more, respectively.
Patients' median age was 32 years (mean, 33.0+/-7.9 years); there were 6832 males (34.6%) and 12,921 females included. Patients were predominantly ethnic Chinese (90.5%). Mean follow-up time was 68.8 days. The mean spherical error corrected was -5.90+/-2.57 D (median, -5.625 D), and outcomes were categorized into low, moderate, or high myopia. The UCVA achieving > or =20/40 has been consistently above 90% since 2000, with 72.8% achieving > or =20/20. More than 93.0% of eyes achieved within +/-1.00 D target in the last 4 years. An improvement in safety was observed since the start of the study, with the best outcomes observed in 2007; loss of 1 and 2 Snellen line BCVA postoperatively was 2.4% and 0.1%, respectively. The overall retreatment rate was 3.8%; 91% of retreated eyes achieved UCVA of > or =20/30. Between 1998 and 2007, there was a significant improvement in postoperative UCVA and BCVA (P<0.001).
Myopic LASIK performed in Asian eyes within a comprehensive LASIK clinical program with appropriate clinical audit governance can be safe and effective, with high refractive predictability. Improvements in the nomograms to prevent undercorrection and to compensate for myopic regression have led to better efficacy after LASIK, with an increasing percentage of patients achieving 20/15 visual acuity postoperatively.
本研究评估了 LASIK 手术治疗近视的疗效、可预测性和安全性,该研究是在亚洲研究人群中进行的一项大规模、前瞻性临床审计的一部分,旨在评估结果和趋势。
前瞻性、非随机、单中心、多医生研究。
我们纳入了 19753 名患者的 37932 只眼,这些患者于 1998 年至 2007 年在新加坡国家眼科中心接受了近视 LASIK 手术。
所有眼睛均接受 LASIK 手术治疗近视。记录术前和术后的屈光度、未矫正视力(UCVA)和最佳矫正视力(BCVA)。
轻度、中度和高度近视(等效球镜度数分别小于-5.00 屈光度[D]、-5.00 D 或以上至小于-10.0 D 和-10.00 D 或以上)的安全性、疗效、屈光预测性、治疗趋势、再治疗率和并发症。
患者的中位年龄为 32 岁(平均 33.0+/-7.9 岁);男性 6832 人(34.6%),女性 12921 人。患者主要为华裔(90.5%)。平均随访时间为 68.8 天。平均球镜误差矫正值为-5.90+/-2.57 D(中位数-5.625 D),结果分为低度、中度或高度近视。自 2000 年以来,UCVA 达到>或=20/40 的比例一直保持在 90%以上,其中 72.8%达到>或=20/20。超过 93.0%的眼睛在过去 4 年达到了 +/-1.00 D 的目标。自研究开始以来,安全性得到了改善,2007 年的结果最好;术后 1 和 2 行 Snellen 视力 BCVA 丧失分别为 2.4%和 0.1%。总体再治疗率为 3.8%;91%的再治疗眼达到>或=20/30 的 UCVA。1998 年至 2007 年间,术后 UCVA 和 BCVA 显著改善(P<0.001)。
在全面的 LASIK 临床计划中,在亚洲人眼内进行的近视 LASIK 手术是安全有效的,具有很高的屈光预测性。为了预防欠矫和补偿近视回退,对列线图进行了改进,从而提高了 LASIK 术后的疗效,术后达到 20/15 视力的患者比例不断增加。