波前引导准分子激光原位角膜磨镶术后满意度和不适症状的临床研究

A clinical study of patient satisfaction and visual symptoms after wavefront-gnided laser in situ keratomileusis

目的 评价波前引导准分子激光原位角膜磨镶术（LASIK）术后患者的满意度及不适症状.方法 前瞻性随机双盲对照研究.拟行LASIK手术的近视患者100例（200眼）,随机分为波前引导组（A组,46例）和传统组（S组,54例）.应用Allegretto Wave 1008准分子激光系统,Moria M2角膜刀制作130或160μm角膜瓣,手术光学区直径≥6.5mm.手术前后均进行明、暗光下的视力、对比敏感度和高阶像差等检查,并于术前填写手术原因（8项）及不适症状问卷（9项）,术后1、3和6个月填写满意度和不适症状问卷（18项）.问卷用模拟刻度表示,总分为10分,分4个等级描述.随访6个月,对相关数据分别行配对t检验、成组f检验、卡方检验或者Pearson相关分析.结果 A组和S组患者均以提高裸眼视力为最主要手术目的 （均为100%,得分9.60vs 9.56）,其次是为了去除眼镜（86.9%vs96.3%,得分7.98 vs 9.30）.术后6个月时,A组和S组对手术满意程度分别为100%和96.3%（得分8.67 vs 8.80）,并且愿意推荐给朋友和家人 91.3%的A组和100%的S组患者对视力提高的速度满意（8.20 vs 8.86）,两组得分差异有统计学意义（t=2.2123,P=0.0294）.术后6个月时,A组和S组有明显眩光、光晕、夜间驾车困难等不适症状的分别为4.3%、0、8.7%和7.4%、7.4%、3.7%,较术前减轻.两组的眼干症状比术前加重,且A组比S组明显（t=3.1761,P=0.0026）.眩光、光晕与手术光学区直径有显著相关性（r=0.2453、0.2098,P＜0.05）.夜间驾车困难与手术过渡区直径、光学区直径、切削深度、术后四阶球差的相关性均有统计学意义（r=0.2871、0.2354、-0.2580、-0.2781,P＜0.05）.结论 波前引导LASIK术后患者的满意度较高,但并不优于传统LASIK 眩光、光晕、夜间驾车困难等不适症状较术前降低,而干眼症高于术前和传统LASIK.

Objective To evaluate patient satisfaction and visual symptoms after wavefront-guided laser in situ keratomileusis （LASIK）. Methods This was a prospective, randomized, double-masked and controlled study. One hundred patients （200 eyes） who received laser in situ keratomileusis using an Allegretto Wave 1008 excimer laser system and a Moria M2 automated microkeratome were induded. The patients were randomly divided into a wavefront-guided ablation group （group A, n=46）and a standard ablation group （group S, n=54）. The examinations included visual acuity and contrast sensitivity during the daytime and under low illumination, higher-order aberrations （HOA）, etc.Patients were required to answer questionnaires that included reasons for surgery （8 items） and satisfaction （9 items） before surgery, and visual symptoms （18 items） 1, 3 and 6 months after surgery. The visual analog scale responses for each question were compiled for analysis as a mean score （0 to 10） and divided into 4 equal categories. The patients were followed up for 6 months.Data were analyzed with paired t test, independent t test, chi-square test and pearson correlation analysis. Results The most frequent motivating factor for surgery was to improve uncorrected visual acuity （UCVA） in group A and group S （both 100%, mean score 9.60 vs 9.56） and next was freedom from spectacles （86.9% vs 96.3%, mean score 7.98 vs 9.30）. At 6 months postoperatively,responses from group A and group S were 100% and 96.3% patients, respectively （mean score, 8.67vs 8.80）, indicating they were satisfied with the treatment and would recommend the operation to their friends or family members 91.3% and 100% of the patients were satisfied with the rate of improvement, but the mean scores were significantly different （8.20 vs 8.86） （t=2.2123, P=0.0294）.The percentage of visual symptoms such as glare, halo and night driving difficulty decreased after LASIK, with 4.3%, 0, 8.7% and 7.4%, 7.4%, 3.7%, respectively, in group A and group S.However, the symptoms of dry eye worsened postoperatively, especially in group A （t=3.1761, P=0.0026）. The symptoms of glare and halo were correlated with the diameter of the optical ablation zone （r=0.2453, 0.2098, P〈0.05）. Night driving difficulty was correlated with the diameter of the transition zone, the diameter of the optical ablation zone, the central depth of the ablation, and postoperative RMS4 （r=0.2871, 0.2354, -0.2580, -0.2781, P〈0.05）. Conclusion Although patient satisfaction is very high after wavefront-guided LASIK, it is not significantly higher than that after standard LASIK. The percentage of visual symptoms such as glare, halo and night driving difficulty decrease postoperatively after wavefront-guided LASIK. However the percentage of dry eye is higher postoperatively after the wavefront-guided than the standard LASIK.