Alió Jorge L, Montés-Mico Robert
Research, Development and Innovation Department, VISSUM Ophthalmologic Institute of Alicante, Alicante, Spain.
Ophthalmology. 2006 Feb;113(2):191-7. doi: 10.1016/j.ophtha.2005.10.004. Epub 2005 Dec 27.
To assess efficacy, safety, predictability, stability, and changes in higher-order aberrations (HOAs) and contrast sensitivity (CS) after wavefront-guided and standard LASIK enhancement for the correction of residual refractive errors.
Prospective, randomized, comparative clinical study.
Twenty eyes of 20 consecutive patients (spherical equivalent [SE], -2.01+/-1.36 diopters [D]) treated with wavefront-guided Zyoptix Ablation Refinement software (ZAR) LASIK and 20 eyes of 20 consecutive patients (SE, -1.81+/-1.21 D) treated with standard Planoscan LASIK, both for residual refractive error enhancement.
Efficacy, safety, predictability, stability, HOAs, and CS were evaluated before and after enhancement at 6 months' follow-up.
Uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), manifest refraction, CS by means of the Functional Acuity Contrast Test, and HOAs by means of Zywave aberrometry were evaluated preoperatively and 6 months after retreatment.
At 6 months postoperatively, UCVA was 20/25 or better in 100% of the eyes. Efficacy indexes were 1.09 for ZAR patients and 0.95 for Planoscan patients. No eyes lost > or =1 line of BCVA; in the ZAR group, 2 eyes gained 1 line and 6 eyes gained > or =2 lines; in the Planoscan group, 3 eyes gained 1 line. The ZAR group showed a percentage of eyes (94.4%) within the 0.5-D range in SE higher than that shown by the Planoscan group (88.8%). After 6 months, the HOA root mean square (RMS) increased on average by a factor of 1.44 for the Planoscan group (P = 0.003). No change or reduction in HOA RMS was found in the ZAR group (factor of 0.96; P>0.01). Contrast sensitivity was reduced in the Planoscan group only at the highest spatial frequency (18 cycles per degree; P<0.01). There was a significant reduction of CS as a function of HOA increase for the Planoscan group (P<0.0001). No changes were observed for the ZAR group at any spatial frequency (1.5-18 cycles per degree; P>0.01).
Wavefront-guided LASIK using the ZAR algorithm is an effective and safe procedure for treatment of residual refractive errors. Wavefront-guided LASIK does not increase HOAs and does not modify CS compared with preoperative values. Wavefront-guided LASIK seems to be better than standard LASIK for retreatments.
评估波前引导和标准准分子原位角膜磨镶术（LASIK）增效治疗残余屈光不正后，其疗效、安全性、可预测性、稳定性以及高阶像差（HOAs）和对比敏感度（CS）的变化。
前瞻性、随机、对照临床研究。
连续20例患者的20只眼（等效球镜度[SE]，-2.01±1.36屈光度[D]）接受波前引导的Zyoptix消融优化软件（ZAR）LASIK治疗，以及连续20例患者的20只眼（SE，-1.81±1.21 D）接受标准的Planoscan LASIK治疗，均用于残余屈光不正的增效治疗。
在增效治疗前及6个月随访后评估疗效、安全性、可预测性、稳定性、HOAs和CS。
术前及再次治疗后6个月评估裸眼视力（UCVA）、最佳矫正视力（BCVA）、显验光、通过功能性视力对比测试评估CS以及通过Zywave像差仪评估HOAs。
术后6个月，100%的术眼UCVA达到20/25或更好。ZAR组患者的疗效指数为1.09，Planoscan组患者为0.95。没有术眼BCVA下降≥1行；在ZAR组，2只术眼提高了1行，6只术眼提高了≥2行；在Planoscan组，3只术眼提高了1行。ZAR组SE在0.5 D范围内的术眼百分比（94.4%）高于Planoscan组（88.8%）。6个月后，Planoscan组的HOA均方根（RMS）平均增加了1.44倍（P = 0.003）。ZAR组未发现HOA RMS有变化或降低（系数为0.96；P>0.01）。仅在最高空间频率（每度18周；P<0.01）时，Planoscan组的对比敏感度降低。对于Planoscan组，CS随着HOA增加而显著降低（P<0.0001）。ZAR组在任何空间频率（每度1.5 - 18周；P>0.01）均未观察到变化。
使用ZAR算法的波前引导LASIK是治疗残余屈光不正的有效且安全的方法。与术前值相比，波前引导LASIK不会增加HOAs且不会改变CS。对于再次治疗，波前引导LASIK似乎优于标准LASIK。
