[关键词]
[摘要]
目的:评估Phorcides算法联合Contoura Vision系统在角膜地形图引导近视矫正术中的有效性与安全性,并与传统波前优化(WFO)模式对比。
方法:采用单中心开放标签试验,纳入2024年6月至2024年12月接受近视矫正手术的患者,根据患者接受的手术类型自然分组,Phorcides算法联合角膜地形图引导为Phorcides组,传统波前优化治疗为WFO组。两组均使用WaveLight EX500准分子激光平台,Phorcides组基于Topolyzer Vario地形图数据,通过Phorcides软件生成个体化切削参数; WFO组采用标准化波前优化方案。主要观察指标为术后3 mo裸眼远视力(UDVA)、最佳矫正远视力(CDVA)、残余等效球镜度(MRSE)、高阶像差(总HOAs、含球差C12、垂直彗差C7、水平彗差C8、三叶草差C6/C9)及并发症发生率。
结果:本研究纳入患者128例256眼,其中Phorcides组64例128眼,WFO组64例128眼。Phorcides组年龄28.1±5.3岁,男34例,女30例。WFO组年龄27.9±5.0岁,男33例,女31例。两组年龄、性别、术前MRSE、术前散光及总HOAs比较无差异(均P>0.05)。术后3 mo,(1)视力与屈光:Phorcides组UDVA≥20/16比例(65.6%)显著高于WFO组(37.5%)(χ2=22.18,P<0.001); Phorcides组MRSE值(-0.07±0.14 D)显著低于WFO组(-0.16±0.21 D)(t=4.12,P<0.001),更接近预期屈光目标; Phorcides组残余散光≤0.50 D比例(92.2%)较WFO组(71.9%)提升20.3%(χ2=16.35,P<0.001); WFO组仅1眼出现CDVA损失≥1行,Phorcides组无CDVA下降病例;(2)高阶像差:Phorcides组总HOAs(0.37±0.07 μm)显著低于WFO组(0.51±0.10 μm)(t=12.84,P<0.001); Phorcides组球差C12(0.21±0.05 μm)、垂直彗差C7(0.09±0.02 μm)及水平彗差C8(0.08±0.02 μm)显著低于WFO组(均P<0.001); 三叶草差C6组间无差异(P=0.056),C9虽有统计学差异(P=0.022),但绝对值微小(<0.06 μm),临床意义有限;(3)并发症:两组均无严重并发症; Phorcides组5眼(3.9%)发生1级DLK,WFO组7眼(5.5%)发生1级DLK,组间发生率无差异(χ2=0.42,P=0.517),经激素治疗后均完全消退。
结论:Phorcides算法通过整合三维角膜地形图数据,可显著提升近视矫正精准性,减少术后残余屈光误差及HOAs累积,且安全性良好,为复杂屈光不正患者提供更优个体化方案。
[Key word]
[Abstract]
AIM: To evaluate the efficacy and safety of Phorcides algorithm combined with Contoura Vision system in topography-guided myopic correction surgery, and compare its clinical outcomes with conventional wavefront-optimized(WFO)mode.
METHODS: A single-center open-label trial was conducted. Patients who underwent myopic correction surgery from June to December 2024 were enrolled and divided into two groups according to surgical protocols. The Phorcides algorithm combined with corneal topography-guided treatment constituted the Phorcides group, while conventional WFO treatment served as the WFO group. Both groups received surgery using the WaveLight EX500 excimer laser platform. In the Phorcides group, individualized ablation profiles were generated by the Phorcides software based on Topolyzer Vario topographic data. The WFO group underwent treatment with a standardized wavefront-optimized protocol.The primary outcome indicators included uncorrected distance visual acuity(UDVA), corrected distance visual acuity(CDVA), manifest residual spherical equivalent(MRSE), higher-order aberrations(HOAs, including spherical aberration C12, vertical coma C7, horizontal coma C8, trefoil aberration C6/C9)and incidence of postoperative complications at 3 mo after surgery.
RESULTS:This study enrolled 128 patients(256 eyes), including 64 patients(128 eyes)in the Phorcides group and 64 patients(128 eyes)in the conventional WFO group. The mean age was 28.1±5.3 y(34 males, 30 females)in the Phorcides group and 27.9±5.0 y(33 males, 31 females)in the WFO group.There were no significant inter-group differences in age, gender, preoperative MRSE and preoperative astigmatism and total higher-order aberrations(HOAs)between the two groups(all P>0.05). At 3 mo postoperatively, 1)visual acuity and refractive outcomes: the proportion of eyes achieving UDVA of 20/16 or better in the Phorcides group was 65.6%, which was obviously higher than 37.5% in the WFO group(χ2=22.18,P<0.001). MRSE in the Phorcides group was -0.07±0.14 D, significantly lower than -0.16±0.21 D in the WFO group(t=4.12, P<0.001), indicating closer alignment with the target refraction. The proportion of eyes with residual astigmatism ≤0.50 D reached 92.2% in the Phorcides group, which was 20.3% higher than 71.9% in the WFO group(χ2=16.35, P<0.001).Only one eye of one-line CDVA loss was observed in the WFO group, while no CDVA decline occurred in the Phorcides group; 2)higher-order aberrations: the total HOAs was 0.37±0.07 μm in the Phorcides group, markedly lower than 0.51±0.10 μm in the WFO group(t=12.84, P<0.001). Spherical aberration C12(0.21±0.05 μm), vertical coma C7(0.09±0.02 μm), and horizontal coma C8(0.08±0.02 μm)in the Phorcides group were all significantly lower than those in the WFO group(all P<0.001). No significant inter-group difference was found in postoperative trefoil aberration C6(P=0.056). Although there was a statistical difference in C9(P=0.022), its absolute difference was less than 0.06 μm with limited clinical significance. 3)complications: no severe adverse complications occurred in either group. Grade 1 diffuse lamellar keratitis(DLK)was found in 5 eyes(3.9%)in the Phorcides group and 7 eyes(5.5%)in the WFO group, with no significant difference in incidence between groups(χ2=0.42, P=0.517), and all of which were completely resolved after hormone therapy.
CONCLUSION:By integrating three-dimensional corneal topography data, the Phorcides algorithm can effectively improve the accuracy of myopia correction, reduce postoperative residual refractive error and accumulation of HOAs with reliable safety. It provides a superior individualized surgical strategy for patients with complex refractive errors.
[中图分类号]
[基金项目]
宜春市科技局科研课题(No.JXYC2025KSA183)