Objective: To study the efficacy, safety, and change in visual quality of a phakic posterior chamber implantable collamer lens with centra FLOW (PPC-ICL V4c) for correcting high myopia. Methods: This was a prospective study of 58 eyes of 32 patients who were candidates for PPC-ICL V4c. The following indicators were compared: preoperative and postoperative uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), preoperative aberrations and aberrations 6 months postoperatively, contrast sensitivity, and the Quality of Life Impact of Refractive Correction (QIRC). All patients were followed up for more than 6 months. Data were analyzed using paired t-tests. Results: Preoperative UCVA (LogMAR visual acuity) and UCVA 6 months after surgery was 1.54±0.26 and -0.04±0.06, respectively. Visual acuity 6 months after surgery improved compared to preoperative acuity (t=30.94, P<0.001). Compared to preoperative BCVA, 56 eyes had equal or better BCVA 6 months after surgery, which accounted for 97%of the total number of eyes. There was an increase of 1 row or better for 28 eyes, which accounted for 48% of the total number of eyes. Postoperative higher-order wavefront aberrations, spherical aberrations, coma, and trefoil root mean square (RMS) were 0.292±0.093 μm, -0.030±0.050 μm, 0.096±0.090 μm, and 0.224±0.091 μm, respectively. Total higher-order aberrations increased and coma was reduced, but the differences were not statistically significant. Spherical aberrations were reduced (t=3.87, P=0.001) and trefoil increased (t=-5.47, P<0.001). All contrast sensitivities 6 months after surgery were better than preoperative levels for 3.0, 6.0, 12.0, and 18.0 cycles/degree. There were also significant differences between the photopic 3.0 and 6.0 cycles/degree and mesopic 6 cycles/degree (t=-2.12, P=0.047; t=-2.51, P=0.021; t=-3.27, P=0.004). The QIRC score for patients improved (t=-2.41, P=0.039) after surgery. Conclusions: Implants of PPC-ICL V4c are a safe and effective surgical method for correcting high myopia. All patients are satisfied with the surgery, which can improve visual quality and quality of life.%目的:观察有晶状体眼后房型人工晶状体(PPC-ICL)V4c植入术矫正高度近视的有效性、安全性及其视觉质量变化.方法:前瞻性临床研究.选择拟行PPC-ICL V4c植入术的高度近视患者32例(58眼).术前及术后6个月分别测量裸眼视力(UCVA)、最佳矫正视力(BCVA)、波前像差、对比敏感度和采用屈光矫正者生活质量量表(QIRC)评价手术前后生活质量.采用配对t检验对数据进行分析.结果:术前及术后6个月患者UCVA(LogMAR)分别为1.54±0.26、-0.04±0.06.术后较术前提高(t=30.94,P<0.001).术后6个月UCVA等于或超过术前BCVA者56眼(97%),其中术后UCVA较术前BCVA提高1行及以上者28眼(48%).术后6个月全眼总高阶像差、球差、彗差、三叶草均方根(RMS)值分别为(0.292±0.093)μm、(-0.030±0.050)μm、(0.096±0.090)μm、(0.224±0.091)μm,其中术后全眼球差RMS值较术前下降(t=3.87,P=0.001),术后全眼三叶草RMS值较术前增加(t=-5.47,P<0.001),高阶像差、彗差与术前差异无统计学意义.术后6个月时3.0、6.0、12.0、18.0 cpd各频率段对比敏感度值与术前相比有所提高,其中明视3.0 cpd、明视6.0 cpd和暗视6.0 cpd与术前差异有统计学意义(t=-2.12,P=0.047;t=-2.51,P=0.021;t=-3.27,P=0.004),余频率段与术前差异均无统计学意义.患者术后QIRC得分较术前提高(t=-2.41,P=0.039).结论:PPC-ICL V4c植入术是矫正高度近视的一种安全有效的方法,患者术后视觉质量与生活质量明显提高.
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