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可植入式角膜胶原晶状体(ICL)与准分子原位角膜磨镶术(LASIK)治疗低度近视的比较。

Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia.

作者信息

Sanders Donald, Vukich John A

机构信息

Center For Clinical Research, Elmhurst, IL 60126, USA.

出版信息

Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c.

Abstract

PURPOSE

To compare the results of laser-assisted in situ keratomileusis (LASIK) and implantable collamer lenses (ICL) in the correction of myopia -4 to -7.88 D.

METHODS

A total of 1678 LASIK eyes from the Davis Duehr Eye Center, Madison, WI, and 144 ICL eyes from the 14-site US FDA Clinical Trial for ICL for Myopia were compared. Both series were concurrently operated on with 4 to 7.88 D of preoperative spherical equivalent of the manifest refraction and were examined at 1 day, 1 week, 1 month, and 6 months postoperatively. The mean baseline myopia was slightly higher in the ICL group (ICL: -6.4 +/- 1.1 D; LASIK: -5.6 +/- 1.1 D). Best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), and refractions were collected prospectively in both series.

RESULTS

BSCVA loss of at least 2 lines was significantly higher in the LASIK series in the early healing period (1 week: 6% vs. 0.7%; P = 0.008), whereas a BSCVA gain of at least 2 lines was statistically better with the ICL at 1 (5% vs. 0.9%, P = 0.001) and 6 months (4% vs. 0.8%, P = 0.013). Proportion of cases seeing 20/15 or better uncorrected (21.6% vs. 7.8%, P < 0.001) and 20/20 or better (67% vs. 57%, P = 0.027) at 6 months postoperatively was better in the ICL group. The ICL was statistically more predictable (attempted vs. achieved) at 6 months; +/-0.50 D (79% ICL vs. 70% LASIK, P = 0.034) and +/-1.0 D (97% ICL vs. 88% LASIK, P < 0.001). Stability was achieved (95% < or = 1.0 D) at the 1-week to 1-month interval for both groups (95% LASIK; 98% ICL). The stability of refraction (< or =0.5 D change) was significantly better in the ICL group than the LASIK group through 6 months. No serious complications occurred in either series.

CONCLUSIONS

The ICL was safer and more effective than LASIK and seems to be a viable alternative to corneal refractive excimer surgery in the treatment of low myopia.

摘要

目的

比较准分子原位角膜磨镶术(LASIK)和可植入式角膜接触镜(ICL)矫正-4至-7.88 D近视的效果。

方法

比较威斯康星州麦迪逊市戴维斯·杜尔眼科中心的1678只接受LASIK手术的眼睛,以及美国食品药品监督管理局(FDA)开展的ICL矫正近视的14个中心的144只接受ICL手术的眼睛。两个队列的患者术前平均等效球镜度数均为4至7.88 D,术后1天、1周、1个月和6个月进行检查。ICL组的平均基线近视度数略高于LASIK组(ICL:-6.4±1.1 D;LASIK:-5.6±1.1 D)。前瞻性收集两个队列的最佳矫正视力(BSCVA)、裸眼视力(UCVA)和验光结果。

结果

在早期愈合阶段(1周:6%对0.7%;P = 0.008),LASIK组至少下降2行的BSCVA损失显著更高,而ICL组在1个月(5%对0.9%,P = 0.001)和6个月(4%对0.8%,P = 0.013)时至少提高2行的BSCVA改善在统计学上更好。术后6个月,ICL组裸眼视力达到20/15或更好(21.6%对7.8%,P < 0.001)和20/20或更好(67%对57%,P = 0.027)的病例比例更高。在6个月时,ICL在统计学上更可预测(预期与实际);±0.50 D(ICL为79%对LASIK为70%,P = 0.034)和±1.0 D(ICL为97%对LASIK为88%,P < 0.001)。两组在术后1周与1个月期间均达到稳定性(95%≤1.0 D)(LASIK为95%;ICL为98%)。ICL组在6个月内的屈光稳定性(变化≤0.5 D)明显优于LASIK组。两个队列均未发生严重并发症。

结论

ICL比LASIK更安全、更有效,似乎是治疗低度近视的角膜屈光性准分子手术的可行替代方案。

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